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U.S. Department of Health and Human Services

Class 2 Device Recall Belos VR

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  Class 2 Device Recall Belos VR 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-0074-04
Recall Event ID 27417
PMA Number P980023/S4 
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Belos VR Implantable Cardioverter Defibrillator
Code Information Serial Numbers: 78112903, 78112904, 78112905, 78112906, 78112907, 78112908, 78112909, 78113004, 78113012, 78113013, 78113014, 78113015, 78113016, 78113017, 78113018, 78113019, 78113020, 78113022, 78113054, 78113055, 78113057, 78113058, 78113059, 78113060, 78113061, 78113062, 78113063, 78113064, 78113066, 78113067, 78113071, 78113082, 78113084, 78113085, 78113086, 78113090, 78113091, 78113092, 78113093, 78113094, 78113095, 78113096, 78113113, 78113114, 78113115, 78113116, 78113117, 78113118, 78113119, 78113120, 78113121, 78113122, 78113123, 78113124.
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 54 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.
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