Events

Recall of Device Recall IVC

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
    26479
  • Event Risk Class
    Class 2
  • Event Number
    Z-0174-04
  • Event Initiated Date
    2003-06-09
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27751
  • 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
    Pull tube on bed may bend or separate causing inoperability of bed or head section to fall.
  • Action
    The 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.

Device

Device Recall IVC
  • Model / Serial
    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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    involved products were distributed to approximately 1100 dealers in the United Stated and to 54 Canadian dealer accounts.
  • Product Description
    Invacare IVC Home Care Bed (Foot Section with new head actuator from Linak.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, One Invacare Way, Elyria OH 44036
  • Source
    USFDA