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U.S. Department of Health and Human Services

Class 2 Device Recall Tilt & Recline Seating System

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  Class 2 Device Recall Tilt & Recline Seating System see related information
Date Initiated by Firm March 10, 2003
Date Posted March 26, 2003
Recall Status1 Terminated 3 on April 13, 2012
Recall Number Z-0682-03
Recall Event ID 25721
510(K)Number k911151  
Product Classification Wheelchair, Powered - Product Code ITI
Product Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs.
Code Information All Model Numbers (excluding the 2nd generation models); Serial Numbers: 93I through 02E
Recalling Firm/
Manufacturer		 Invacare Corp
1200 Taylor St
Elyria OH 44035
Manufacturer Reason
for Recall		 A short circuit within the charger harness may cause heat damage to the units with potential for fire.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 20,956 units
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.
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.
510(K) Database 510(K)s with Product Code = ITI and Original Applicant = TARSYS ENGINEERING, INC.
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