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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 System see related information
Date Initiated by Firm December 15, 2003
Date Posted January 14, 2004
Recall Status1 Terminated 3 on September 13, 2008
Recall Number Z-0344-04
Recall Event ID 27910
Product Classification Wheelchair, Powered - Product Code ITI
Product Invacare 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 Contact Ms. 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
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.
Total Product Life Cycle TPLC 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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