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
|