Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.
FDA Recall Z-0076-04 · Posted 2003-10-31
Recalling FirmBiotronik Inc
Recall StatusTerminated
Product CodeLWS
Date Initiated2003-09-24
Date Terminated2005-02-17
Product Quantity794 devices
Reason for Recall
Potential for early depletion of Implantable Cardioverter Defibrillator battery.
Firm Action
Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up to reprogram the affected devices.
Root Cause
Other
Distribution Pattern
The firm distributes to physicians located throughout the US.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.