Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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.