Events

Recall of Device Recall Tilt & Recline Seating System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invacare Corp.

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
    25721
  • Event Risk Class
    Class 2
  • Event Number
    Z-0682-03
  • Event Initiated Date
    2003-03-10
  • Event Date Posted
    2003-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26363
  • 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
    A short circuit within the charger harness may cause heat damage to the units with potential for fire.
  • Action
    On 3/10/2003, the firm mailed recall letters to all affected dealer accounts. The dealers were asked to contact all customers who have purchased powered wheelchairs with the optional Tarsys Seating System.

Device

Device Recall Tilt & Recline Seating System
  • Model / Serial
    All Model Numbers (excluding the 2nd generation models); Serial Numbers: 93I through 02E
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The scooters were shipped to dealerships located nationwide, and to foreign distributors located in Thailand, So. Africa, Hong Kong, New Zealand, Japan, Maylasia, Korea, Isreal, Australia. 92% of affected units were shipped to domestic accounts.
  • Product Description
    Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs.
  • Manufacturer
    Invacare Corp

Manufacturer

Invacare Corp
  • Manufacturer Address
    Invacare Corp, 1200 Taylor St, Elyria OH 44035
  • Source
    USFDA