Z-1775-2010
iBOT 4000 Mobility System Battery pack
Independence Technology, LLC / initiated 2010-02-22 / Terminated / root cause: design
Independence Technology LLC began a recall of iBOT 4000 Mobility System Battery pack on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1775-2010
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Independence Technology, LLC
- Product
- iBOT 4000 Mobility System Battery pack.
- Product code
- IMK Wheelchair, Stair Climbing
- 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.
- Root cause tag
- design
- FDA root 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.
- Product codes and lots
- 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.
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