Toyota Motor Corp. recalled 2.17 million vehicles in the United States on Thursday to address accelerator pedals that could become entrapped in floor mats or jammed in driver's side carpeting, prompting federal regulators to close its investigation into the embattled automaker.
The Transportation Department said it had reviewed more than 400,000 pages of Toyota documents to determine whether the scope of the company's recalls for pedal entrapment was sufficient.
"As a result of the agency's review, (the National Highway Traffic Safety Administration) asked Toyota to recall these additional vehicles, and now that the company has done so, our investigation is closed," said NHTSA administrator David Strickland.
Toyota has now recalled more than 14 million vehicles globally to fix gas pedals and other safety problems since 2009. U.S. regulators said earlier this month that electronic flaws were not to blame for reports of sudden, unintended acceleration. The company paid the U.S. government a record $48.8 million in fines for its handling of three recalls.
The world's No. 1 auto company said more than half of the vehicles under recall were being added to a massive 2009 recall that fixed gas pedals getting trapped in the floor mat.
The Japanese automaker said it would add three models to the 2009 pedal entrapment recall: about 600,000 4Runner SUVs from the 2003-2009 model years; 761,000 RAV4 compact SUVs from the 2006-2010 model years; and 17,000 Lexus LX 570s from the 2008-2011 model years.
The recall also includes 372,000 RX 330, RX 350 and RX 400H vehicles from the 2004 through early 2007 model years and 397,000 2004-2006 Toyota Highlander SUVs and hybrid versions to replace floor carpet covering and retention clips on the driver's side that could interfere with the accelerator pedal arm.
Toyota also recalled 20,000 2006 through early 2007 GS 300 and GS 350 all-wheel drive vehicles to change the shape of a plastic pad embedded in the driver's side floor carpet that could cause pedal interference.
Thursday, February 24, 2011
Honda Recalls: Fit, Freed and City for Defectivs Springs, May Cause Car to Stall
TOKYO — Honda is recalling nearly 700,000 Fit, Freed and City compact cars around the world for a defective spring part that may cause the engine to stall.
No accidents have been reported related to the problem, but at least 72 complaints were filed in Japan, and 29 abroad, Honda Motor Co. spokesman Tomohiro Okada said Thursday.
Recalled are 167,000 vehicles in Japan, 156,000 in China, and 233,000 in the rest of Asia, Tokyo-based Honda said. About 122,000 cars are being recalled in North America.
The spring was placed improperly in a small box inside the engine, so that, in some cases, the problem could cause the engine to stall, Okada said
No accidents have been reported related to the problem, but at least 72 complaints were filed in Japan, and 29 abroad, Honda Motor Co. spokesman Tomohiro Okada said Thursday.
Recalled are 167,000 vehicles in Japan, 156,000 in China, and 233,000 in the rest of Asia, Tokyo-based Honda said. About 122,000 cars are being recalled in North America.
The spring was placed improperly in a small box inside the engine, so that, in some cases, the problem could cause the engine to stall, Okada said
Many errors taking place because physicians not listening to patients.
Many errors taking place because physicians not listening to patients.
Modern Healthcare (2/24, Carlson) reports, "The latest report from the Dartmouth Atlas Project -- Improving Patient Decision-Making in Health Care, which was conducted in conjunction with the Foundation for Informed Medical Decision Making -- concludes that if physicians educated and listened to their patients more thoroughly, unwanted variation would decline." Investigators took an "in-depth look at medical conditions involving decisions for elective care in cases where the statistics don't recommend a single course of action." They found that much of the difference is attributable to "physicians' preferences, not differences in patient populations. But in cases of elective procedures, giving a patient a treatment he doesn't want is as much an error as wrong-site surgery," the co-author of the study said.
Modern Healthcare (2/24, Carlson) reports, "The latest report from the Dartmouth Atlas Project -- Improving Patient Decision-Making in Health Care, which was conducted in conjunction with the Foundation for Informed Medical Decision Making -- concludes that if physicians educated and listened to their patients more thoroughly, unwanted variation would decline." Investigators took an "in-depth look at medical conditions involving decisions for elective care in cases where the statistics don't recommend a single course of action." They found that much of the difference is attributable to "physicians' preferences, not differences in patient populations. But in cases of elective procedures, giving a patient a treatment he doesn't want is as much an error as wrong-site surgery," the co-author of the study said.
Wednesday, February 23, 2011
Ford Recalls F-150 Pickups for Airbags that Could Deploy Without Warning
Ford Recalls Nearly 150,000 F-150 Pickups
Recall is prompted by concerns the truck's airbags could deploy without warning.
A wiring short could trigger the airbags in some 2005 and 2006 model Ford F-150 pickups.
Ford is recalling 144,000 F-150 pickups from the 2005 and 2006 model years because of concerns that the airbags may deploy without warning, the automaker said on Tuesday.
The National Highway Traffic Safety Administration advised Ford to recall the F-150 after investigating 238 reports of accidental airbag deployment. Seventy-seven injuries have been reported, including chipped teeth, minor burns and cuts to the arms, hands and face.
Road vibrations and regular driving can cause the airbag wires to rub against the metal edge of the horn plate. The rubbing may eventually cut through the insulation on the wire, which then may short and cause the airbag to deploy.
Ford is recalling 135,000 trucks in the United States and 9,000 in Canada. However, the risk of accidental airbag deployment is relatively low, Ford said.
Ford changed the wiring for the 2007 model year to avoid the issue
Recall is prompted by concerns the truck's airbags could deploy without warning.
A wiring short could trigger the airbags in some 2005 and 2006 model Ford F-150 pickups.
Ford is recalling 144,000 F-150 pickups from the 2005 and 2006 model years because of concerns that the airbags may deploy without warning, the automaker said on Tuesday.
The National Highway Traffic Safety Administration advised Ford to recall the F-150 after investigating 238 reports of accidental airbag deployment. Seventy-seven injuries have been reported, including chipped teeth, minor burns and cuts to the arms, hands and face.
Road vibrations and regular driving can cause the airbag wires to rub against the metal edge of the horn plate. The rubbing may eventually cut through the insulation on the wire, which then may short and cause the airbag to deploy.
Ford is recalling 135,000 trucks in the United States and 9,000 in Canada. However, the risk of accidental airbag deployment is relatively low, Ford said.
Ford changed the wiring for the 2007 model year to avoid the issue
Supreme Court finds No Preemption in Lap Belt Only Case: Protects Family
Williamson v. Mazda
The Supreme Court in a unanimous judgment will let Mazda be sued in California courts in a case involving a woman who died while wearing a seat belt across her lap in her family's minivan.
The high court in a unanimous judgment agreed to let the lawsuit go forward, despite complaints from the car company that federal regulators gave it an option on whether to install lap belts or lap-and-shoulder belts in the middle seats in the back of the van.
Justice Stephen Breyer, who wrote the majority judgment, said the only way that Mazda would be immune is if the "significant objective" of the federal regulation was to give auto manufacturers a choice of which seat belts to install.
The Transportation Department "gave no indication that its safety goals required the mixture of seatbelt types that resulted from manufacturers' ability to choose different options," said Justice Sonia Sotomayor in a concurring judgment.
Added Breyer: The more important reason why DOT did not require lap-and-shoulder belts for rear inner seats was that it thought that this requirement would not be cost-effective. The agency explained that it would be significantly more expensive for manufacturers to install lap-and shoulder belts in rear middle and aisle seats than in seats next to the car doors. But that fact - the fact that DOT made a negative judgment about cost effectiveness - cannot by itself show that DOT sought to forbid common law tort suits in which a judge or jury might reach a different conclusion."
Justice Bryer sited Geier often, pulling it back into the preemption argument.
"In Geier, then, the regulation's history, the agency explanation, and its consistently held interpretive views indicated that the regulation sought to maintain manufacturer choice in order to further significant regulatory objectives. Here, these same considerations indicate the contrary. We consequently conclude that, even though the state tort suit may restrict the manufacturer's choice, it does not "stan[d] as an obstacle to the accomplishment . . . of the full purposes and objectives" of federal law."
The case is Williamson v. Mazda, 08-1314. Click here for the Opinion: 08-1314_Opinion_(02-23-11).pdf
The Supreme Court in a unanimous judgment will let Mazda be sued in California courts in a case involving a woman who died while wearing a seat belt across her lap in her family's minivan.
The high court in a unanimous judgment agreed to let the lawsuit go forward, despite complaints from the car company that federal regulators gave it an option on whether to install lap belts or lap-and-shoulder belts in the middle seats in the back of the van.
Justice Stephen Breyer, who wrote the majority judgment, said the only way that Mazda would be immune is if the "significant objective" of the federal regulation was to give auto manufacturers a choice of which seat belts to install.
The Transportation Department "gave no indication that its safety goals required the mixture of seatbelt types that resulted from manufacturers' ability to choose different options," said Justice Sonia Sotomayor in a concurring judgment.
Added Breyer: The more important reason why DOT did not require lap-and-shoulder belts for rear inner seats was that it thought that this requirement would not be cost-effective. The agency explained that it would be significantly more expensive for manufacturers to install lap-and shoulder belts in rear middle and aisle seats than in seats next to the car doors. But that fact - the fact that DOT made a negative judgment about cost effectiveness - cannot by itself show that DOT sought to forbid common law tort suits in which a judge or jury might reach a different conclusion."
Justice Bryer sited Geier often, pulling it back into the preemption argument.
"In Geier, then, the regulation's history, the agency explanation, and its consistently held interpretive views indicated that the regulation sought to maintain manufacturer choice in order to further significant regulatory objectives. Here, these same considerations indicate the contrary. We consequently conclude that, even though the state tort suit may restrict the manufacturer's choice, it does not "stan[d] as an obstacle to the accomplishment . . . of the full purposes and objectives" of federal law."
The case is Williamson v. Mazda, 08-1314. Click here for the Opinion: 08-1314_Opinion_(02-23-11).pdf
Fosamax and Femur Fractures- Fosamax Leading to Femur Fractures in Women
Bisphosphonates may increase risk for atypical leg fractures.
Bloomberg News (2/23, Randall) reports bisphosphonates "designed to prevent bone breaks in older women may actually increase the risk of a rare form of leg fractures," suggests a study in the Journal of the American Medical Association.
According to the Los Angeles Times (2/23, Roan) "Booster Shots" blog, researchers examined "205,466 women age 68 and older with osteoporosis who took a bisphosphonate for several years and identified 716 women who had an atypical fracture." When compared with a control group of "3,580 women who had not taken bisphosphonates, the long-term use of the drug was linked to 2.7 times higher odds of hospitalization for an atypical fracture." Overall, in women with "five or more years of bisphosphonate use, an atypical fracture occurred in 0.13% of them in the subsequent year."
WebMD (2/22, Boyles) added that last fall, the Food and Drug Administration announced that it would "require label changes on bisphosphonates to warn of a 'possible risk of atypical thigh bone fracture' in long-term users." Although it is "not clear whether bisphosphonates are the cause, atypical femur fractures...have been predominantly reported in patients taking bisphosphonates," agency officials noted in a news release issued at the time
Bloomberg News (2/23, Randall) reports bisphosphonates "designed to prevent bone breaks in older women may actually increase the risk of a rare form of leg fractures," suggests a study in the Journal of the American Medical Association.
According to the Los Angeles Times (2/23, Roan) "Booster Shots" blog, researchers examined "205,466 women age 68 and older with osteoporosis who took a bisphosphonate for several years and identified 716 women who had an atypical fracture." When compared with a control group of "3,580 women who had not taken bisphosphonates, the long-term use of the drug was linked to 2.7 times higher odds of hospitalization for an atypical fracture." Overall, in women with "five or more years of bisphosphonate use, an atypical fracture occurred in 0.13% of them in the subsequent year."
WebMD (2/22, Boyles) added that last fall, the Food and Drug Administration announced that it would "require label changes on bisphosphonates to warn of a 'possible risk of atypical thigh bone fracture' in long-term users." Although it is "not clear whether bisphosphonates are the cause, atypical femur fractures...have been predominantly reported in patients taking bisphosphonates," agency officials noted in a news release issued at the time
Tuesday, February 22, 2011
Hidden Dangers of Seat Heaters to Disabled Drivers and Passengers
It’s Time to Make Seat Heaters Safer
Today, Safety Research & Strategies called on the National Highway Traffic Safety Administration and the industry to correct a longstanding safety problem: seat heaters that injure disabled drivers and passengers. With no government or industry-wide standards, manufacturers have installed a variety of seat heater systems – some that reach temperatures significantly above human tolerances or have no automatic shut-off mechanism – or both. While most drivers know when to turn a hot seat off, occupants with lower body sensory deficits don’t feel the burn. The medical literature has been documenting serious and permanent burn injuries from car seat heaters to occupants with paralysis or diabetes since 2003. Disabled motorists have been complaining about the problem to NHTSA since, at least, 2002. The industry’s response has been to bury a warning in the owner’s manual. NHTSA’s approach to seat heater defects has been: no flames, no problem. These are preventable injuries – and it’s time government and industry began preventing them.
The medical community has joined us in this campaign. We encourage readers to do the same by sending NHTSA, The Alliance of Automobile Manufacturers, and the National Mobility Equipment Dealers Association letters supporting changes in standards and practices
Today, Safety Research & Strategies called on the National Highway Traffic Safety Administration and the industry to correct a longstanding safety problem: seat heaters that injure disabled drivers and passengers. With no government or industry-wide standards, manufacturers have installed a variety of seat heater systems – some that reach temperatures significantly above human tolerances or have no automatic shut-off mechanism – or both. While most drivers know when to turn a hot seat off, occupants with lower body sensory deficits don’t feel the burn. The medical literature has been documenting serious and permanent burn injuries from car seat heaters to occupants with paralysis or diabetes since 2003. Disabled motorists have been complaining about the problem to NHTSA since, at least, 2002. The industry’s response has been to bury a warning in the owner’s manual. NHTSA’s approach to seat heater defects has been: no flames, no problem. These are preventable injuries – and it’s time government and industry began preventing them.
The medical community has joined us in this campaign. We encourage readers to do the same by sending NHTSA, The Alliance of Automobile Manufacturers, and the National Mobility Equipment Dealers Association letters supporting changes in standards and practices
Thursday, February 17, 2011
Chevrolet Cobalts recalled for Steering Problems
notice is sent to you in accordance with the requirements of the National Traffic and Motor
Vehicle Safety Act.
General Motors has decided that a defect that relates to motor vehicle safety exists in certain
2005-2010 model year Chevrolet Cobalt vehicles; 2005 model year Pontiac Pursuit; 2005-2006
model year Pontiac G4; 2006 model year Pontiac G5 Pursuit; and 2007-2010 model year
Pontiac G5 vehicles equipped with electric power steering. As a result, GM is conducting a
safety recall. We apologize for this inconvenience. However, we are concerned about your
safety and continued satisfaction with our products.
IMPORTANT
• Your vehicle is involved in safety recall 10023.
• Schedule an appointment with your GM dealer.
• This service will be performed for you at no charge.
Why is your
vehicle being
recalled?
Your vehicle may have a condition in which a sudden loss of power
steering assist could occur at any time while driving the vehicle. If
the power steering assist is lost, a chime will sound and a "Power
Steering" message will be displayed in the Driver Information Center
to inform you of the condition. Steering control will be maintained,
as the vehicle defaults to a manual steering mode. If power steering
assist is lost, it may require greater driver effort at low vehicle
speeds, for example, below 15 mph (25 km/h). Unless the driver
compensates for this additional effort, it may increase the risk of a
crash.
Typically, the next time the vehicle is started, the power steering
assist will return and the "Power Steering" message will no longer
be displayed.
What will we
do?
Your GM dealer will replace the electric power steering motor. This
service will be performed for you at no charge. Because of service
scheduling requirements, it is likely that your dealer will need your
vehicle longer than the actual service correction time of
approximately 40 minutes.
If your vehicle is within the New Vehicle Limited Warranty, your
dealer may provide you with shuttle service or some other form of
courtesy transportation while your vehicle is at the dealership for this
repair. Please refer to your Owner Manual and your dealer for
details on courtesy transportation.
What should
you do?
You should contact your GM dealer to arrange a service
appointment as soon as possible.
Page 9 March 2010 Bulletin No.: 10023
Did you already
pay for this
repair?
The enclosed form explains what reimbursement is available and
how to request reimbursement if you have paid for repairs for the
recall condition. If you had this condition corrected, you may have
received the new motor. Please contact your dealer to determine if
the motor in your vehicle requires replacement.
Do you have
questions?
If you have questions or concerns that your dealer is unable to
resolve, please contact the appropriate Customer Assistance Center
at the number listed below.
Division Number
Text Telephones
(TTY)
Chevrolet 1-800-630-2438 1-800-833-2438
Pontiac 1-800-620-7668 1-800-833-7668
Guam 1-671-648-8450
Puerto Rico – English 1-800-496-9992
Puerto Rico – Español 1-800-496-9993
Virgin Islands 1-800-496-9994
If after contacting your dealer and the Customer Assistance Center, you are still not satisfied
we have done our best to remedy this condition without charge and within a reasonable time,
you may wish to write the Administrator, National Highway Traffic Safety Administration, 1200
New Jersey Avenue, SE, Washington DC 20590, or call the toll-free Vehicle Safety Hotline at
1.888.327.4236 (TTY 1.800.424.9153), or go to http://www.safercar.gov.
Federal regulation requires that any vehicle lessor receiving this recall notice must forward a
copy of this notice to the lessee within ten days.
Scott Lawson
Director,
Customer and Relationship Services
Enclosure
Vehicle Safety Act.
General Motors has decided that a defect that relates to motor vehicle safety exists in certain
2005-2010 model year Chevrolet Cobalt vehicles; 2005 model year Pontiac Pursuit; 2005-2006
model year Pontiac G4; 2006 model year Pontiac G5 Pursuit; and 2007-2010 model year
Pontiac G5 vehicles equipped with electric power steering. As a result, GM is conducting a
safety recall. We apologize for this inconvenience. However, we are concerned about your
safety and continued satisfaction with our products.
IMPORTANT
• Your vehicle is involved in safety recall 10023.
• Schedule an appointment with your GM dealer.
• This service will be performed for you at no charge.
Why is your
vehicle being
recalled?
Your vehicle may have a condition in which a sudden loss of power
steering assist could occur at any time while driving the vehicle. If
the power steering assist is lost, a chime will sound and a "Power
Steering" message will be displayed in the Driver Information Center
to inform you of the condition. Steering control will be maintained,
as the vehicle defaults to a manual steering mode. If power steering
assist is lost, it may require greater driver effort at low vehicle
speeds, for example, below 15 mph (25 km/h). Unless the driver
compensates for this additional effort, it may increase the risk of a
crash.
Typically, the next time the vehicle is started, the power steering
assist will return and the "Power Steering" message will no longer
be displayed.
What will we
do?
Your GM dealer will replace the electric power steering motor. This
service will be performed for you at no charge. Because of service
scheduling requirements, it is likely that your dealer will need your
vehicle longer than the actual service correction time of
approximately 40 minutes.
If your vehicle is within the New Vehicle Limited Warranty, your
dealer may provide you with shuttle service or some other form of
courtesy transportation while your vehicle is at the dealership for this
repair. Please refer to your Owner Manual and your dealer for
details on courtesy transportation.
What should
you do?
You should contact your GM dealer to arrange a service
appointment as soon as possible.
Page 9 March 2010 Bulletin No.: 10023
Did you already
pay for this
repair?
The enclosed form explains what reimbursement is available and
how to request reimbursement if you have paid for repairs for the
recall condition. If you had this condition corrected, you may have
received the new motor. Please contact your dealer to determine if
the motor in your vehicle requires replacement.
Do you have
questions?
If you have questions or concerns that your dealer is unable to
resolve, please contact the appropriate Customer Assistance Center
at the number listed below.
Division Number
Text Telephones
(TTY)
Chevrolet 1-800-630-2438 1-800-833-2438
Pontiac 1-800-620-7668 1-800-833-7668
Guam 1-671-648-8450
Puerto Rico – English 1-800-496-9992
Puerto Rico – Español 1-800-496-9993
Virgin Islands 1-800-496-9994
If after contacting your dealer and the Customer Assistance Center, you are still not satisfied
we have done our best to remedy this condition without charge and within a reasonable time,
you may wish to write the Administrator, National Highway Traffic Safety Administration, 1200
New Jersey Avenue, SE, Washington DC 20590, or call the toll-free Vehicle Safety Hotline at
1.888.327.4236 (TTY 1.800.424.9153), or go to http://www.safercar.gov.
Federal regulation requires that any vehicle lessor receiving this recall notice must forward a
copy of this notice to the lessee within ten days.
Scott Lawson
Director,
Customer and Relationship Services
Enclosure
Volkswagen Jettas, Audis and Golfs and fuel pump failures
Volkswagen AG vehicles are under review by the U.S. National Highway Traffic Safety Administration after reports of engines stalls, some at highway speed, that may be related to fuel-pump failures.
The auto-safety regulator received reports of one accident and 160 complaints from owners and the company about engine loss of power and stalling, NHTSA said in a posting on its website today. The power loss and stalling was related to high-pressure pumps failing and contaminating the fuel system with debris, the agency said.
About half of the reports involved stalling with “many of these alleging stall incidents at highway speeds in traffic with no restart,” the agency said.
NHTSA is reviewing model years 2009 and 2010 of the Volkswagen Jetta and Golf and the Audi A3 that have TDI clean- diesel engines, totaling about 97,272 vehicles.
The regulator, which received 52 of the complaints directly and the rest through the Wolfsburg, Germany-based automaker, upgraded its investigation to an engineering analysis, a step that can lead to a recall.
“We take these matters very seriously and are cooperating fully with NHTSA during its investigation,” Sheriece Matias, a U.S.-based spokeswoman for Volkswagen, said in an e-mail. “We will continue to work closely with the agency as the analysis continues
The auto-safety regulator received reports of one accident and 160 complaints from owners and the company about engine loss of power and stalling, NHTSA said in a posting on its website today. The power loss and stalling was related to high-pressure pumps failing and contaminating the fuel system with debris, the agency said.
About half of the reports involved stalling with “many of these alleging stall incidents at highway speeds in traffic with no restart,” the agency said.
NHTSA is reviewing model years 2009 and 2010 of the Volkswagen Jetta and Golf and the Audi A3 that have TDI clean- diesel engines, totaling about 97,272 vehicles.
The regulator, which received 52 of the complaints directly and the rest through the Wolfsburg, Germany-based automaker, upgraded its investigation to an engineering analysis, a step that can lead to a recall.
“We take these matters very seriously and are cooperating fully with NHTSA during its investigation,” Sheriece Matias, a U.S.-based spokeswoman for Volkswagen, said in an e-mail. “We will continue to work closely with the agency as the analysis continues
Dorel Juvienile Group Recalls 800,000 Child Saftey Seats for failure to lock properly
NEW YORK (CNNMoney) -- Dorel Juvenile Group has recalled nearly 800,000 child safety seats because they do not always lock properly, the government said Monday.
The recall covers certain infant, convertible and booster child restraint systems that were made between May 2008 and April 2009, the National Highway Traffic Safety Administration said. The seats were sold individually or as part of a "travel system" with a stroller.
NHTSA said the harness locking and release button on the seats does not always return to its locked position, which could lead to loose straps. In the event of a crash, the child wouldn't be tightly fastened in, which could result in injuries, the agency said.
As a remedy, Dorel will send registered owners a small tube of "food-grade lubricant" that is designed to prevent sticking and ensure that the harness button works properly.
Dorel said in a statement that the recall "is being conducted out of an abundance of caution with no reported incidents or injuries."
"Parents and caregivers are being provided detailed information on how to make the simple recommended adjustments to their car seat," the company said.
NHTSA said consumers can continue to use the seats until the lubricant is applied, but the agency said caregivers should make sure harness is properly adjusted and locked.
The recall covers certain infant, convertible and booster child restraint systems that were made between May 2008 and April 2009, the National Highway Traffic Safety Administration said. The seats were sold individually or as part of a "travel system" with a stroller.
NHTSA said the harness locking and release button on the seats does not always return to its locked position, which could lead to loose straps. In the event of a crash, the child wouldn't be tightly fastened in, which could result in injuries, the agency said.
As a remedy, Dorel will send registered owners a small tube of "food-grade lubricant" that is designed to prevent sticking and ensure that the harness button works properly.
Dorel said in a statement that the recall "is being conducted out of an abundance of caution with no reported incidents or injuries."
"Parents and caregivers are being provided detailed information on how to make the simple recommended adjustments to their car seat," the company said.
NHTSA said consumers can continue to use the seats until the lubricant is applied, but the agency said caregivers should make sure harness is properly adjusted and locked.
Wednesday, February 16, 2011
Toyo Tire recall
NHTSA Campaign ID Number: 11T001
Synopsis:
Toyo Tire is recalling certain Toyo brand tires, models Versado CUV P245/55 R19 103T, Versado CUV P235/55Rr20 102T, Versado CUV 235/55 R18 100V, Versado CUV P255/65R18 109S, Versado LX II 215/60Rr16 95V, Open Country All Terrain LT285/70 R17 121S, and Tourevo LS II 245/45R18 96V; and Nitto brand Terra Grappler All Terrain 255/55R18 109S, produced from September 19, 2010, through October 2, 2010. The rubber chemical mixture used in some of the recalled tires does not meet Toyo's specification for these tires. Sections of the tread may become detached, potentially causing loss of vehicle control, possibly resulting in a crash. Toyo will notify owners and replace the tires free of charge, including mounting, balancing and taxes. The safety recall is expected to begin on or about February 18, 2011. Owners may contact Toyo toll-free at 1-800-442-8696 (6:30 am to 5:00pm pacific time) or Nitto at 1-888-529-8200 (8am to 5pm pacific time).
For more information for this particular recall, please go to 11T001.
Thank you,
Recalls Subscription Team
Office of Defects Investigation (ODI)
National Highway Traffic Safety Administration (NHTSA)
U.S. Department of Transportation (DOT)
Synopsis:
Toyo Tire is recalling certain Toyo brand tires, models Versado CUV P245/55 R19 103T, Versado CUV P235/55Rr20 102T, Versado CUV 235/55 R18 100V, Versado CUV P255/65R18 109S, Versado LX II 215/60Rr16 95V, Open Country All Terrain LT285/70 R17 121S, and Tourevo LS II 245/45R18 96V; and Nitto brand Terra Grappler All Terrain 255/55R18 109S, produced from September 19, 2010, through October 2, 2010. The rubber chemical mixture used in some of the recalled tires does not meet Toyo's specification for these tires. Sections of the tread may become detached, potentially causing loss of vehicle control, possibly resulting in a crash. Toyo will notify owners and replace the tires free of charge, including mounting, balancing and taxes. The safety recall is expected to begin on or about February 18, 2011. Owners may contact Toyo toll-free at 1-800-442-8696 (6:30 am to 5:00pm pacific time) or Nitto at 1-888-529-8200 (8am to 5pm pacific time).
For more information for this particular recall, please go to 11T001.
Thank you,
Recalls Subscription Team
Office of Defects Investigation (ODI)
National Highway Traffic Safety Administration (NHTSA)
U.S. Department of Transportation (DOT)
Tuesday, February 15, 2011
Recalled medical devices mostly untested
Recalled medical devices mostly untested, report says.
Two of the major television networks and a number of newspapers and consumer medical sites discussed a study published online Feb. 14 in the Archives of Internal Medicine about a possible link between fast approval of some medical devices and their subsequent recall. ABC World News (2/14, story 7, 2:55, Sawyer) reported "a new warning about some of the medical devices so many Americans have implanted," including "replacement hips and knees, heart valves," and "pacemakers."
The CBS Evening News (2/14, story 6, 2:25, Couric) reported, "The FDA approves new medical devices in the hopes of saving lives, but in 2006, some devices were linked to more than 2,800 deaths and close to 120 injuries. Today," a paper in "the Archives of Internal Medicine urged the FDA to improve the way devices are tested before they reach the public."
On the front of its Business Day section, the New York Times (2/15, B1, Meier) reports, "Most medical devices recalled in recent years by the Food and Drug Administration because they posed a high risk to patients were not rigorously studied before being cleared for sale." Researchers Diana M. Zuckerman, PhD, and Paul Brown, of the National Research Center for Women & Families, along with Steven E. Nissen, MD, of the Cleveland Clinic, "found that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing."
"Researchers examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives," the Washington Post (2/15, Stein) reports. "Most of the devices -- 71 percent -- had been approved without undergoing testing in people."
On its front page, the Los Angeles Times (2/15, A1, Zajac) reports, "Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review," and "only 21 of the recalls in the new study involved products approved after clinical trials."
"The study found that most medical devices that were recalled over serious risks to patients were cleared through the Food and Drug Administration's 510(k) approval process or were exempt from regulatory scrutiny entirely," the Minneapolis Star Tribune (2/15, Moore) reports, explaining that "the 510(k) process requires device manufacturers to prove a new product is 'substantially equivalent' to one currently on the market -- usually without clinical data to prove the product is safe and effective." Because of previous criticism of this pathway to approval from both Congressional officials and consumer advocacy groups, "Dr. Jeffrey Shuren, the FDA's new device chief, has announced changes to strengthen the 510(k) process, and the Institute of Medicine will weigh in with the findings of its own review this summer."
Millions "may be at risk." According to the AP (2/15, Tanner), an invited commentary accompanying the study "says the analysis shows that 'millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data.'"
Modern Healthcare (2/15, McKinney) quotes the study authors' conclusion: "Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy."
Two of the major television networks and a number of newspapers and consumer medical sites discussed a study published online Feb. 14 in the Archives of Internal Medicine about a possible link between fast approval of some medical devices and their subsequent recall. ABC World News (2/14, story 7, 2:55, Sawyer) reported "a new warning about some of the medical devices so many Americans have implanted," including "replacement hips and knees, heart valves," and "pacemakers."
The CBS Evening News (2/14, story 6, 2:25, Couric) reported, "The FDA approves new medical devices in the hopes of saving lives, but in 2006, some devices were linked to more than 2,800 deaths and close to 120 injuries. Today," a paper in "the Archives of Internal Medicine urged the FDA to improve the way devices are tested before they reach the public."
On the front of its Business Day section, the New York Times (2/15, B1, Meier) reports, "Most medical devices recalled in recent years by the Food and Drug Administration because they posed a high risk to patients were not rigorously studied before being cleared for sale." Researchers Diana M. Zuckerman, PhD, and Paul Brown, of the National Research Center for Women & Families, along with Steven E. Nissen, MD, of the Cleveland Clinic, "found that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing."
"Researchers examined the 113 devices that the FDA recalled between 2005 and 2009 for posing serious health risks, including endangering patients' lives," the Washington Post (2/15, Stein) reports. "Most of the devices -- 71 percent -- had been approved without undergoing testing in people."
On its front page, the Los Angeles Times (2/15, A1, Zajac) reports, "Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review," and "only 21 of the recalls in the new study involved products approved after clinical trials."
"The study found that most medical devices that were recalled over serious risks to patients were cleared through the Food and Drug Administration's 510(k) approval process or were exempt from regulatory scrutiny entirely," the Minneapolis Star Tribune (2/15, Moore) reports, explaining that "the 510(k) process requires device manufacturers to prove a new product is 'substantially equivalent' to one currently on the market -- usually without clinical data to prove the product is safe and effective." Because of previous criticism of this pathway to approval from both Congressional officials and consumer advocacy groups, "Dr. Jeffrey Shuren, the FDA's new device chief, has announced changes to strengthen the 510(k) process, and the Institute of Medicine will weigh in with the findings of its own review this summer."
Millions "may be at risk." According to the AP (2/15, Tanner), an invited commentary accompanying the study "says the analysis shows that 'millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data.'"
Modern Healthcare (2/15, McKinney) quotes the study authors' conclusion: "Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy."
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