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U.S. Department of Health and Human Services

Class 2 Device Recall Invacare bariatric bed

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 Class 2 Recall
Invacare bariatric bed
see related information
Date Posted November 14, 2011
Recall Status1 Terminated on July 02, 2013
Recall Number Z-0187-2012
Recall Event ID 59461
Product Classification Bed, Therapeutic, Ac-Powered, Adjustable Home-Use - Product Code LLI
Product Invacare 600 lb. Bariatric Bed, Head motor extension cable used on component numbers BAR5490 and BAR5490IVC. These components are part of the following Bed Model Number(s): BAR600, BARPKGCA, BAR600IVC, BARPKGIVC-1633, and BARPKG.
Code Information Model Number(s): BAR600, BARPKGCA, BAR600IVC, BARPKGIVC-1633, and BARPKG. 35747 serial numbers available from Invacare.
Recalling Firm/
Manufacturer
Invacare Corporation
1200 Taylor St
Elyria, Ohio 44035-6248
Manufacturer Reason
for Recall
Invacare Corporation decided to recall the products because risk analysis reveals that miskeying or disconnection of the head motor extension cable during bed set-up may result in product damage, or in rare instances, the potential for fire.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action On 9/19/11, Invacare sent Recall Notificaiton Letters to their customers. They instructed their customers to quarantine the product, complete and return a response form.
Quantity in Commerce 35,747
Distribution Distribution Nationwide and to United Arab Emirates, Dominican Republic, Egypt, Guam, Mexico, & Virgin Islands.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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