Events

Recall of Device Recall Junction Boxes

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
    73577
  • Event Risk Class
    Class 2
  • Event Number
    Z-2402-2016
  • Event Initiated Date
    2016-03-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148109
  • 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, ac-powered adjustable hospital - Product Code FNL
  • Reason
    The firm recently identified a quality issue with the junction box used in the invacare bariatric bed. they discovered that the junction box may omit sparks which could result in a fire in the presence of flammable materials.
  • Action
    Invacare sent an Urgent Medical Device Recall letter dated May 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call Invacares recall support line at (877) 413-6008, Monday  Friday, 8 a.m.  5 p.m. EST, for assistance.

Device

Device Recall Junction Boxes
  • Model / Serial
    Model #'s:1104343 & 1104345
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including DC and PR. Internationally Canada.
  • Product Description
    Junction Boxes, || Product Usage: || The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
  • 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