ClearanceBrief
Recall Z-1775-2010 ยท IMK Wheelchair, Stair Climbing

Independence Technology LLC

iBOT 4000 Mobility System Battery pack.

DateJun 5, 2010 (initiated Feb 22, 2010)
StatusTerminated
ReasonA 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 causeDevice Design
ActionThe company sent Medical Device Field Correction letters to all customers on February 22, 2010 by certified mail.
Quantity192 devices
DistributionNationwide and to the United Kingdom.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.