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U.S. Department of Health and Human Services

Class 2 Device Recall Belos DRT

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  Class 2 Device Recall Belos DRT see related information
Date Initiated by Firm September 24, 2003
Date Posted October 31, 2003
Recall Status1 Terminated 3 on February 28, 2005
Recall Number Z-0073-04
Recall Event ID 27417
PMA Number P000009/S5 
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Belos DR-T Implantable Cardioverter Defibrillator
Code Information Serial Numbers: 79640026, 79640028, 79640030, 79640031, 79640032, 79640033, 79640035, 79640037, 79640039, 79640044, 79640048, 79640049, 79640053, 79640058, 79640060, 79640062, 79640064, 79640065, 79640070, 79640078, 79640079, 79640080, 79640081, 79640082, 79640085, 79640086, 79640087, 79640088, 79640089, 79640091, 79640093, 79640094, 79640095, 79640097, 79640104, 79640116, 79640117, 79640121, 79640239, 79640247, 79640252, 79640323, 79640324.
Recalling Firm/
Manufacturer		 Biotronik Inc
6024 Jean Road
Lake Oswego OR 97035-5369
For Additional Information Contact
800-547-0394
Manufacturer Reason
for Recall		 Potential extended charge time anomalies.
FDA Determined
Cause 2		 Other
Action Firm issued a letter dated September 24, 2003 recommending physicians schedule an immediate follow-up with affected patients.
Quantity in Commerce 43 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.
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