Events

Recall of Device Recall Tarsys 2G 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 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
    27910
  • Event Risk Class
    Class 2
  • Event Number
    Z-0343-04
  • Event Initiated Date
    2003-12-15
  • Event Date Posted
    2004-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30726
  • 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
    The weld joints on the seat back may fail and cause possible injury to the patient.
  • Action
    The firm notified their consignees by letter and telephone on 12/15/2003.

Device

Device Recall Tarsys 2G Tilt & Recline Seating System
  • Model / Serial
    Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx, and 02Axxx.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were shipped to domestic dealerships located nationwide, and to foreign accounts in Canada, China, Oman, and West Indies.
  • Product Description
    Invacare 2G Tarsys Seating System, Model 2GTR.
  • 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