Events

Recall of Device Recall Invacare bariatric bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59461
  • Event Risk Class
    Class 2
  • Event Number
    Z-0187-2012
  • Event Initiated Date
    2011-06-23
  • Event Date Posted
    2011-11-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102837
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    bed - Product Code LLI
  • Reason
    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.
  • 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.

Device

Device Recall Invacare bariatric bed
  • Model / Serial
    Model Number(s): BAR600, BARPKGCA, BAR600IVC, BARPKGIVC-1633, and BARPKG. 35747 serial numbers available from Invacare.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution Nationwide and to United Arab Emirates, Dominican Republic, Egypt, Guam, Mexico, & Virgin Islands.
  • Product Description
    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.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA