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U.S. Department of Health and Human Services

Class 2 Device Recall Tarsys 2G Tilt & Recline Seating System

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 Class 2 Device Recall Tarsys 2G Tilt & Recline Seating Systemsee related information
Date Initiated by FirmDecember 15, 2003
Date PostedJanuary 14, 2004
Recall Status1 Terminated 3 on September 13, 2008
Recall NumberZ-0344-04
Recall Event ID 27910
Product Classification Wheelchair, Powered - Product Code ITI
ProductInvacare 2G Tarsys Seating System, Model 2GTR.
Code Information Serial Numbers: 00Axxx thru 00Lxxx, 01Axxx thru 01Lxxx, and 02Axxx.
Recalling Firm/
Manufacturer
Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information ContactMs. Janice Brownlee
440-329-6595
Manufacturer Reason
for Recall
The weld joints on the seat back may fail and cause possible injury to the patient.
FDA Determined
Cause 2
Other
ActionThe firm notified their consignees by letter and telephone on 12/15/2003.
Quantity in Commerce5,990 units
DistributionThe units were shipped to domestic dealerships located nationwide, and to foreign accounts in Canada, China, Oman, and West Indies.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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