| Class 2 Device Recall Belos VR | |
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
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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
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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 |
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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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PMA Database | PMAs with Product Code = LWS
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