Events

Recall of Tracer IV wheelchairs

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
    67134
  • Event Risk Class
    Class 2
  • Event Number
    Z-0634-2014
  • Event Initiated Date
    2012-04-16
  • Event Date Posted
    2014-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124755
  • 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
    Wheelchair, mechanical - Product Code IOR
  • Reason
    The wheels on tracer iv wheelchairs (tracer iv 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.
  • Action
    The firm, Invacare, sent a memo dated December 4, 2013 to their customer. The memo described the product, problem, and actions to be taken . On February 8, 2012 representatives from the recalling firm visited the customer to investigate the complaint. The wheelchairs were returned and destroyed. If you have any question, please call 440-329-6875 or email: ssaigal@invacare.com.

Device

Tracer IV wheelchairs
  • Model / Serial
    Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution: Michigan only.
  • Product Description
    Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 || For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.
  • 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