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U.S. Department of Health and Human Services

Class 2 Device Recall IVC

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 Class 2 Device Recall IVCsee related information
Date Initiated by FirmJune 09, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on May 08, 2014
Recall NumberZ-0174-04
Recall Event ID 26479
Product Classification Bed, Therapeutic, Ac-Powered, Adjustable Home-Use - Product Code LLI
ProductInvacare IVC Home Care Bed (Foot Section with new head actuator from Linak.
Code Information Foot section model numbers and serial number ranges: Model # Beginning S/N Ending S/N 5490IVC 03D891256 03E035155 5890IVC 03D889942 03E002241 5491IVC 03E969254 03E433379 5891IVC 03E970154 03E971163  Bed Models that include the recalled food sections: 5310IVC, 5311IVC, 5410IVC, 5411IVC  Bed package model numbers which include the affected Beds and foot sections:  BED-21VC, BED-4IVC, BED-9IVC, BED-10IVC, BED-19IVC, BED-21IVC, BED-22IVC, BED-23IVC, BED-24IVC, BED-25IVC, BED-26IVC, BED-27IVC, BED-28IVC, BED-29IVC, BED-32IVC, BED-33IVC, BED-34IVC, BED-35IVC, BED-36IVC, BED-37IVC, CBED-2IVC, CBED-4IVC, CBED-4BIVC, CBED-11IVC, CBED-11BIVC, CBED-12IVC, CBED-12BIVC, CBED-19IVC, CBED-22IVC, CBED-23IVC, CBED-26IVC, CBED-28IVC.
Recalling Firm/
Manufacturer		 Invacare Corporation
One Invacare Way
Elyria OH 44036
For Additional Information ContactStephen D. Neese
800-333-6900
Manufacturer Reason
for Recall		Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.
FDA Determined
Cause 2		Other
ActionThe firm began telephoning direct consignees on 6/9/03 and also began sending recall letters to these consignees on 6/9/03. The letter provides a list of affected units shipped to the consignee and the serial number of the affected foot section on the bed. If the consignee indicated they wanted to perform the correction themselves then the indicated number of corrective bracket installation kits are being sent. Also they are given the option of having an Invacare authorized service center perform the correction. This is for units in their possession and also at patient homes. As of October 2003 enough corrective kits have been forwarded to dealers to correct all involved units.
Quantity in Commerce5926
Distributioninvolved products were distributed to approximately 1100 dealers in the United Stated and to 54 Canadian dealer accounts.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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