Company: Biotronik, Inc.
Date of Enforcement Report: 11/26/03
Class: II
PRODUCT
a) Belos VR Implantable Cardioverter Defibrillator (ICD)
with version A-K00.1.U/1 programmer software.
Recall # Z-0076-04;
b) Belos VR-T Implantable Cardioverter Defibrillator (ICD)
with version A-K00.1.U/1 programmer software.
Recall # Z-0077-04.
REASON
Potential for early depletion of Implantable Cardioverter Defibrillator battery.
CODE
a) Serial Numbers: 7811xxxx;
b) Serial Numbers: 7814xxxx.
RECALLING FIRM/MANUFACTURER
Biotronik, Inc., Lake Oswego, OR, by letter dated September 24, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,066 devices.
DISTRIBUTION
Nationwide.
