Date Initiated by Firm | February 22, 2010 |
Date Posted | June 05, 2010 |
Recall Status1 |
Terminated 3 on October 01, 2010 |
Recall Number | Z-1775-2010 |
Recall Event ID |
54643 |
PMA Number | P020033 |
Product Classification |
Stair Climbing Wheelchair - Product Code IMK
|
Product | iBOT 4000 Mobility System Battery pack. |
Code Information |
Serial Numbers 020605-001001 to 021007-001451 with Battery Pack(s) Revision 2.0. Serial number contains the month/year of manufacture followed by a sequential number. |
Recalling Firm/ Manufacturer |
Independence Technology LLC 45 Technology Dr Warren NJ 07059-5148
|
For Additional Information Contact | William Farnella 908-722-3767 |
Manufacturer Reason for Recall | A thermal breaker in the battery pack has the potential to open due to overheating and disable one third of the cells in the affected battery pack. |
FDA Determined Cause 2 | Device Design |
Action | The company sent Medical Device Field Correction letters to all customers on February 22, 2010 by certified mail. |
Quantity in Commerce | 192 devices |
Distribution | Nationwide and to the United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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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PMA Database | PMAs with Product Code = IMK
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