Class 2 Device Recall INDEPENDENCE iBOT 4000 Mobility System

• Date Initiated by Firm: February 22, 2010
• Date Posted: June 05, 2010
• Recall Status: Terminated 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: 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