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U.S. Department of Health and Human Services

Class 2 Device Recall Powered Scooters

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  Class 2 Device Recall Powered Scooters see related information
Date Initiated by Firm February 10, 2003
Date Posted February 25, 2003
Recall Status1 Terminated 3 on April 12, 2012
Recall Number Z-0574-03
Recall Event ID 25495
510(K)Number k010135  
Product Classification Wheelchair, Powered - Product Code ITI
Product Invacare Lynx and Panther Scooters, motorized 3-wheeled vehicles.
Code Information Model Numbers: (Lynx) LX-3, SX-3, SX-3P; (Panther) LX-4, MX-4. Serial Numbers: 99J through 00G.
Recalling Firm/
Manufacturer
Invacare Corp
1200 Taylor St
Elyria OH 44036-2125
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 the scooters.
Quantity in Commerce 5,029 scooters
Distribution The scooters were shipped to dealerships located nationwide, and to foreign distributors located in Barbados, Argentina, Isreal, and Bermuda.
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 = INVACARE CORP.
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