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Product Recall
Medical Device Field Correction - September 2009Invacare TDXTM SR Power Wheelchairs with Stability Lock, Model Numbers TDXSR, TDXSR-HD, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, TDXSR-MCG-HD and TDXSRV-HDDistributed Between February 2008 - September 2008 Affected Serial Number Ranges for TDXSR with 150lb, 165lb and 300 lb Weight Capacity: 08Bxxxxxx Affected Serial Number Ranges for TDXSR with 400 lb Weight Capacity: 08Bxxxxxx - 08Ixxxxxx Posted September 24, 2009 This recall is being initiated to address the issue of the stability lock on the wheelchair not functioning and also to address improvements implemented by Invacare. Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may exhibit a tendency to do one or more of the following: •veer to one side •rock forward onto its front riggings •drive in an unintended circular motion; and/or •fall forward or to one side and injure the user. The following situations could occur if this feature is not corrected: •a user's chair could fall off a ramp without guardrails and possibly have the chair fall on them •bump into nearby objects or, •be thrown from the chair. Consequently, and even though remote, an uncorrected Stability Lock feature could lead to serious injury (i.e. broken bones, lacerations) or death for the user due to loss of control of the wheelchair. If your Invacare TDX SR Power Wheelchair falls into the serial number ranges noted above, please contact your dealer promptly to have the stability lock feature corrected. If you have questions, please contact Invacare at: Email: Recalls@invacare.com Fax: 877-619-7996 Phone: 800-333-6900 Invacare Corporation, One Invacare Way, Elyria, OH 44036-2125 Medical Device Field Correction - June 2009Kuschall's K-Junior Wheelchairs with Pushbuggy HandlePosted July 2009 A field correction is being conducted for Kuschall's K-Junior Wheelchairs with Pushbuggy Handle, Distributed between July 17, 2005 and March 1, 2006. We have discovered that the pushbuggy handle was breaking where it attaches to the chair. This failure presents the following hazards:
The following serial numbers are affected by this field action:
To determine if your Kuschall wheelchair is involved in the corrective action, check the serial number label on the product. The replacement of the handle is to be completed promptly. Please contact your Kuschall provider to schedule the installation of the handle.
Additional questions can be directed to: Medical Device Field Correction Update - November 2009Invacare TDX® SP Power Wheelchairs with Stability LockDistributed Between August 2006 - September 2008 Affected Serial Number Range: 06Hxxxxxx - 08Ixxxxxx Posted November 20, 2009 In November of 2007, Invacare initiated a recall for its TDXSP Power Wheelchair with Stability Lock. We are expanding on our original notification to address issues that have been determined to exist with our stability lock feature and improvements implemented by Invacare. Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may exhibit a tendency to do one or more of the following: The following situations could occur if this feature is not corrected: Consequently, and even though remote, an uncorrected Stability Lock feature could lead to serious injury (i.e. broken bones, lacerations) or death for the user due to loss of control of the wheelchair. If your Invacare TDX SP Power Wheelchair falls into the serial number range noted above, please contact your dealer promptly to have the stability lock feature corrected. If you have questions, please contact Invacare at: Email: Recall@invacare.com Fax (toll free): 877-619-7996 Phone: 800-333-6900 Mail: Regulatory Affairs, Invacare Corporation, One Invacare Way, Elyria, OH 44036-2125 Medical Device Field Correction - November 2007CareGuard Mattresses Provided Since September 2006 In Combination with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds, and the ValueCare Bed Series Semi Electric Bed, and Full and Half-Length RailsAffected Mattress Model Numbers: CG10180 or CG10180CA Affected Bed Package Model Numbers: BED24IVC, BED25IVC, BED24CA, BED25CA Posted November 2007 A field correction is being conducted for CareGuard mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed and Full and Half-Length Rails. These mattresses were manufactured between September 2006-July 2007. In September 2006, Invacare published a statement that its new bed systems met the voluntary FDA Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. That statement accurately reflected what we believed to be true at that time. Recently, however, we discovered that the CareGuard mattresses provided after that date did not meet all of the requirements of the Guidance when we tested them with the Invacare rails and beds. Though the requirements of the Guidance are voluntary, we support the intention of the Guidance and seek your cooperation in reducing the risk of entrapment with those mattresses supplied since the September statement and used as part of an Invacare bed system. The affected mattresses can be identified by looking on the law label tag for the following information: Model # CG10180 or CG10180CA and a BLACK date code with the corresponding month and year of manufacture (i.e. September 2006, October 2006....August 2007). Please note that any mattresses in your possession that have a RED date code on the law label are not affected by this action. If you have received individual affected mattresses that are being used with Invacare beds and full length bed rails, model numbers 6628, 6629 or 6650 or bed packages that contained the affected mattresses, Invacare is requiring that you move the bed rail in accordance with instructions that will be sent to you. By moving the rail, our tests have shown a new mattress, rail and bed combination does pass all requirements of the Guidance. If you have received individual affected mattresses that are being used with Invacare beds and half bed rails, model number 6630, Invacare is requesting that you contact Customer Service and request Part No. 6022, which is a kit that contains a 2" convoluted foam pad, warning label and installation instructions. Testing has shown that the addition of the foam pad on a new mattress with Invacare half rails / bed combination meets the Guidance requirements. These actions are to be completed promptly, recorded on the provided tracking sheet and the tracking sheet is to be returned to Invacare. Additional questions can be directed to: Invacare's Customer Relationship Management Group Email: Recalls@invacare.com Fax (toll-free): 877-619-7996 Phone: 800-333-6900 Mail: Invacare Corporation, One Invacare Way, Elyria, OH 44036-2125 Medical Device Field Correction - September 2007Innerspring Mattresses Associated with IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric BedAffected Mattress Model Numbers: 5185 or 5185XL Affected Bed Package Model Numbers: BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633, VCPKGIVC-1633 or VCPKGIVC2-1633 Posted September 2007 A field correction is being conducted for innerspring mattresses associated with Invacare's IVC Bed Series Full Electric Beds, Semi-Electric Beds and Manual Beds and the ValueCare Bed Series Semi Electric Bed. These mattresses were manufactured between June 28, 2007-July 12, 2007. Invacare has recently become aware that these specific mattresses, Models 5185 and 5185XL manufactured between June 28, 2007-July 12, 2007, when used in combination with our IVC and ValueCare Series of manual, semi-electric and electric beds and associated bed rails, do not meet some of the requirements of the voluntary FDA Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. Use of these particular mattresses in combination with Invacare beds and bed rails may put users at increased risk of entrapment. The affected mattresses are identified by the Model # 5185/5185XL AND a BLACK date code of June or July 2007 on the law label. If you have received individual affected mattresses or bed packages that contained the affected mattresses, Invacare is requiring that you destroy the affected mattresses and document your actions on a tracking sheet that will be sent to you with other information. The destruction of the mattress(es) is to be completed promptly. Additional questions can be directed to: Invacare's Customer Relationship Management Group Email: Recalls@invacare.com Fax (toll-free): 877-619-7996 Phone: 800-333-6900 Mail: Invacare Corporation, One Invacare Way, Elyria, OH 44036-2125 Medical Device Field Correction - March 2007Certain Custom Configurations of the Invacare® Storm TDX™ Power Wheelchair Series
Model Numbers TDX3-PS, TDX4-PS and TDX3-SE-PS
A field correction is being conducted for certain custom configurations of the Invacare Storm TDX Power Wheelchair Series, Model Numbers TDX3-PS, TDX4-PS and TDX3-SE-PS, manufactured between October 9, 2006 – February 28, 2007. These particular models of power wheelchairs, with Tilt and Recline seating, or Tilt and Recline seating with Power Legs (with or without the elevate option) or power center mount are the only ones affected by this field action. For these special custom configurations, a remote possibility exists when the recline function is programmed to work together with the power legs or the power center mount, that a user could recline the backrest too far due to a software problem. In doing so the user could possibly fall out of the chair, or damage the actuator, creating the potential for a later sudden failure of back support. If your Invacare Storm TDX Power Wheelchair is involved in the corrective action, you will be receiving a software update, version 1.3.1. via an SD card along with installation instructions and instructions for inspecting the recline actuator for damage. The installation of the software and the inspection of the recline actuator is to be completed promptly. Additional questions can be directed to:Invacare's Customer Relationship Management Group Email: Recalls@invacare.com Fax (toll-free): 877-619-7996 Phone: 800-333-6900 Mail: Invacare Corporation, One Invacare Way, Elyria, OH 44036-2125 Medical Device Field Correction - October 2006Invacare IVC Bed Series Foot Section Models: 5890 IVC and 5490 IVC
A field correction is being conducted for the Invacare IVC Bed Series, Foot Section Models 5890 IVC and 5490 IVC, manufactured between September 15, 2006 and September 22, 2006 There is the possibility that the extension tube and foot actuator need adjustment for proper operation and to mitigate any possible safety risk. If your IVC bed is involved in the corrective action, you will be receiving information from Invacare that will include an instruction sheet for performing the adjustment if necessary. The adjustment, if necessary, is to be completed promptly. Additional questions can be directed to:Invacare's Customer Relationship Management Group Email: Recalls@invacare.com Fax (toll-free): 877-619-7996 Phone: 800-333-6900 Mail: Invacare Corporation, One Invacare Way, Elyria, OH 44036-2125 Medical Device Field Correction - July 2006Kuschall Design K3/K4 (Airlite) Series of Manual WheelchairPosted August 2, 2006 A field correction is being conducted for Kuschall's K3/K4 Series of Manual Wheelchair, Model Airlite. The affected devices were distributed between July 2005 - March 2006. If the user has chosen to install optional anti-tipper(s) on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break. This could result in unintended falling with resultant injury. A more robust design has been verified and validated by the manufacturer to withstand the anticipated forces of use and will be made available to the consignees of the previous anti-tip part as a free replacement via written notification, so that they can install it on their consumer's chair. To determine if your Kuschall wheelchair is involved in the corrective action, check the serial number label on the product. The replacement of the anti-tips is to be completed promptly. Please contact your Kuschall provider to schedule the installation of the anti-tips. Additional questions can be directed to: Mr. John Dmytriw Email:jdmytriw@invacare.com Phone: 440-329-6838 Medical Device Field Correction - November 2005 Invacare 220 Scooter as manufactured for Invacare Corporation by Tung Keng Enterprises - The possibility exists that the throttle spring could break, preventing the scooter from stopping upon release of the throttle handle. Users could manually pull the throttle handle back to the center position and thereby stop the scooter, but the handle has been designed to spring back to the center position when released and this is what users are accustomed to doing. This failure of the throttle to return to the center position when released could result in unintended movement of the scooter. Although Invacare is not the manufacturer of this product, as the distributor of this product we are obligated to take action to ensure the safety of the users of this product. Invacare feels that addressing this problem expeditiously will prevent potential harm to users of the Invacare 220 Scooter. This field action affects Invacare brand Invacare 220 scooters distributed from September 2004 (when first offered) through August 2005. The replacement of the throttle assembly is required as soon as possible to mitigate the potential safety risk. The actual installation typically takes less than 20 minutes. It is very important to the manufacturer and Invacare that this matter be addressed as quickly as possible. By promptly replacing the throttle assembly, you will be ensuring continued reliable service of the scooter. Please contact your Invacare provider to schedule the installation of the replacement throttle assembly. More InformationFor service or more information regarding field corrections, please contact your local Invacare dealer. To locate a dealer in your area, utilize our Dealer Locator or call Invacare: US - 800-333-6900 or Canada - 800-668-5324 to speak with a customer service representative. |
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