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U.S. Department of Health and Human Services

Class 2 Device Recall INDEPENDENCE iBOT 4000 Mobility System

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  Class 2 Device Recall INDEPENDENCE iBOT 4000 Mobility System see related information
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
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.
PMA Database PMAs with Product Code = IMK and Original Applicant = INDEPENDENCE TECHNOLOGY, L.L.C.
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