Events

Recall of Device Recall 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
    75939
  • Event Risk Class
    Class 2
  • Event Number
    Z-1183-2017
  • Event Initiated Date
    2016-12-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151794
  • 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, therapeutic, ac-powered, adjustable home-use - Product Code LLI
  • Reason
    A quality issue with the junction box used in the bariatric bed junction that may omit sparks and result into a fire.
  • Action
    All customers were notified via letter with return receipt. This notification will include a provider letter, provider response card, impacted unit list and a consumer letter. Consignees will be instructed conduct sub-recalls as necessary. Follow-up telephone calls will be made to nonresponders.

Device

Device Recall Bariatric Bed
  • Model / Serial
    BARPKG-IVC 1633
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Products were distributed in the following states: AK, AL, AR, CA, CO, CT, FL, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. No foreign accounts
  • Product Description
    Bariatric Bed - BARPKG-IVC 1633
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1 Invacare Way, Elyria OH 44035-4190
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA