Events

Recall of TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair

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
    61555
  • Event Risk Class
    Class 2
  • Event Number
    Z-1905-2012
  • Event Initiated Date
    2012-04-06
  • Event Date Posted
    2012-06-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108412
  • 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, powered - Product Code ITI
  • Reason
    Invacare corporation decided to recall the product because of a potential risk of fire and serious injury. the post fuse assemblies could potentially have a short between the positive ring terminal and the terminal battery bracket which would create an alternate current path around the fuse.
  • Action
    Invacare sent an "URGENT: RECALL INFORMATION" letter dated June 7, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. THe letters instructs customers to examine their inventory for the affected product and quarantine any product found. AProvider Response Form was enclosed for customers to complete and return via fax to 888-345-0289. Contact the firm at 888-641-9738 for assistance with this recall.

Device

TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair
  • Model / Serial
    TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, and FDX-MCG.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and Puerto Rico and the countries of Australia, Germany, New Zealand.
  • Product Description
    TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX, FDX-CG, FDXEURO-14, FDX-MCG. Mrf. By: Invacare Corporation, 1200 Taylor Street, Elyria, OH 44035. || Intended to provide mobility to a person restricted to a sitting position.
  • 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