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Product Recall
Medical Device Field Correction - December 2007Invacare TDX® SP Power Wheelchair with Stability LockDistributed between October 2006 - September 2007 Posted December 2007 A field correction is being conducted for the Invacare Storm TDX SP Power Wheelchair Series, Model Numbers TDXSP, TDXSP-CG, TDXSP-MCG, manufactured between October 2006 - September 2007. 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 veer to one side or it may rock forward onto its front riggings. The Stability Lock feature is intended to prevent the wheelchair from rocking forward when the wheelchair is stopped suddenly following movement. The design of the Stability Lock, utilizing resistive cylinders, has generally proven quite effective, but in some cases, the elevator bolt was not adjusted properly causing the cylinder pins to remain compressed and/or the rear swing arm pivot to be overly tight. This would not allow the rear swing arms to adequately drop away from the cylinders. Current units coming from the factory are being manufactured using improved processes and more defined adjustments to ensure the Stability Lock feature is engaging properly and consistently on all units. Invacare is requesting that all affected consignees inspect and/or adjust the Stability Lock feature on their wheelchairs in accordance with the instructions and provided repair kit. If your Invacare Storm TDX SP Power Wheelchair is involved in the corrective action, you will be receiving a kit that contains washers for adjustment of the stability lock, if necessary and instructions for performing the inspection and adjustment. The inspection and, if necessary, adjustment of the stability lock is to be completed promptly. Additional questions can be directed to: Invacare's Customer Relationship Management Group Email: CRMGroup@Invacare.com Fax (toll-free): 877-619-7996 Phone: 800-333-6900 Mail: Dennis Wolter 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: Recall@Invacare.com Fax (toll-free): 877-619-7996 Phone: 800-333-6900 (8am -8pm EST) Mail: Dennis Wolter Invacare Corporation, 39400 Taylor Parkway, North Ridgeville OH 44039 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: Recall@Invacare.com Fax (toll-free): 877-619-7996 Phone: 800-333-6900 (8am -8pm EST) Mail: Dennis Wolter Invacare Corporation, 39400 Taylor Parkway, North Ridgeville OH 44039 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: CRMGroup@Invacare.com Fax (toll-free): 877-619-7996 Phone: 800-333-6900 Mail: Larry Smith 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: CRMGroup@Invacare.com Fax (toll-free): 877-619-7996 Phone: 800-333-6900 Mail: Larry Smith, Invacare Corporation, One Invacare Way, Elyria, OH 44036-2125 Medical Device Field Correction - September 2006Invacare Continuing Care Group Long Term Care Beds
Models IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS A field correction is being conducted for the Invacare Continuing Care Group Long Term Care Beds, Models IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS, distributed between April 20, 2006 and July 25, 2006 There is the possibility that the washing instruction caution label located on the junction box of these beds is in French instead of English. If your ICCG bed is involved in the corrective action, you will be receiving an English language washing instruction caution label to be placed on the junction box over the French label. The replacement of the label is to be completed promptly. Additional questions can be directed to:
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. Medical Device Field Correction - June 2005Invacare Pronto Series Power WheelchairsPosted June 24, 2005 A field correction is being conducted for Invacare’s Pronto Series power wheelchairs, Models M50, M51 and M61 that have office style arms. These devices were distributed between January 20, 2005 – March 15, 2005. There is a possibility that if the arm of the wheelchair is overloaded, the joystick mounting bracket (see A on Figure 1) and/or the arm pivot (see B on Figure 1) may fail. This failure may cause the user or a caregiver to fall if leaning on the arm, and could result in injury. Though no injuries have been reported yet, Invacare feels that addressing this issue now will prevent problems in the future.
To determine if your Pronto series wheelchair is involved in the corrective action, check the serial number label on the product. The impacted serial number range is from 05Axxx (January 2005) thru and including 05Cxxx (March 2005). The replacement of the arms is to be completed promptly. Please contact your Invacare provider to schedule the installation of the replacement arms. Additional questions can be directed to:Invacare’s Customer Relationship Management Group Email: CRMGroup@Invacare.com Fax: 877-619-7996 Phone: 800-347-5440, ext. 2000 Mail: Larry Smith Invacare Corporation, One Invacare Way, Elyria, OH 44036-2125 More InformationFor service or more information regarding field corrections, please contact your local Invacare dealer, visit Invacare's website at www.invacare.com to locate a dealer in your area with our Dealer Locator, or call Invacare at 1-800-333-6900 (enter option 3 and then option 1) to speak to a Customer Service Representative. |
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