Z-0343-04

Invacare 2G Tarsys Seating System, Model 2GR

Name: Z-0343-04 Invacare 2G Tarsys Seating System, Model 2GR
Creator: Invacare Corporation
Published: 2003-12-15
License: https://open.fda.gov/license/

Invacare GmbH / initiated 2003-12-15 / Terminated / root cause: manufacturing process

FDA source

Invacare Corporation began a recall of Invacare 2G Tarsys Seating System, Model 2GR on 2003-12-15. The reason FDA records is "The weld joints on the seat back may fail and cause possible injury to the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0343-04
Status: Terminated
Initiated: 2003-12-15
Posted: 2004-01-14
Terminated: 2008-09-13
Recalling firm: Invacare GmbH
Product: Invacare 2G Tarsys Seating System, Model 2GR.
Product code: ITI Wheelchair, Powered
Reason for recall: The weld joints on the seat back may fail and cause possible injury to the patient.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm notified their consignees by letter and telephone on 12/15/2003.
Quantity in commerce: 5,990 units
Distribution: The units were shipped to domestic dealerships located nationwide, and to foreign accounts in Canada, China, Oman, and West Indies.
Product codes and lots: Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx, and 02Axxx.

Product code ITI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)