iBOT 4000 Mobility System Battery pack.
FDA Recall Z-1775-2010 · Posted 2010-06-05
Recalling FirmIndependence Technology LLC
Recall StatusTerminated
Product CodeIMK
Date Initiated2010-02-22
Date Terminated2010-10-01
Product Quantity192 devices
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.
Firm Action
The company sent Medical Device Field Correction letters to all customers on February 22, 2010 by certified mail.
Root Cause
Device Design
Distribution Pattern
Nationwide and to the United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.