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U.S. Department of Health and Human Services

Class 2 Device Recall Belos VRT

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  Class 2 Device Recall Belos VRT see related information
Date Initiated by Firm September 24, 2003
Date Posted October 31, 2003
Recall Status1 Terminated 3 on February 17, 2005
Recall Number Z-0077-04
Recall Event ID 27418
PMA Number P980023/S8 
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Belos VR-T Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.
Code Information Serial Numbers: 7814xxxx
Recalling Firm/
Biotronik Inc
6024 Jean Road
Lake Oswego OR 97035-5369
For Additional Information Contact
800-547-0394 Ext. 394
Manufacturer Reason
for Recall
Potential for early depletion of Implantable Cardioverter Defibrillator battery.
FDA Determined
Cause 2
Action Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up to reprogram the affected devices.
Quantity in Commerce 272 devices
Distribution The firm distributes to physicians located throughout the US.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = BIOTRONIK, INC.