iBOT 4000 Mobility System Battery pack.
FDA device recall Z-1775-2010 · posted 2010-06-05 · Terminated
Recall details
- Recalling firm
- Independence Technology LLC
- 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.
- Action taken
- The company sent Medical Device Field Correction letters to all customers on February 22, 2010 by certified mail.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IMK
- Quantity affected
- 192 devices
- Distribution
- Nationwide and to the United Kingdom.
- Date initiated
- 2010-02-22
- Date posted
- 2010-06-05
- Date terminated
- 2010-10-01
- Location
- Warren, NJ
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