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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
Consumer Instructions Contact the recalling firm for information
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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