Class 2 Device Recall Belos VR

• Date Initiated by Firm: September 24, 2003
• Date Posted: October 31, 2003
• Recall Status: Terminated on February 17, 2005
• Recall Number: Z-0076-04
• Recall Event ID: 27418
• PMA Number: P980023/S4
• Product Classification: Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
• Product: Belos VR Implantable Cardioverter Defibrillator (ICD) with version A-K00.1.U/1 programmer software.
• Code Information: Serial Numbers: 7811xxxx
• Recalling Firm/ Manufacturer: 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: Other
• Action: Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up to reprogram the affected devices.
• Quantity in Commerce: 794 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