Date Initiated by Firm |
September 24, 2003 |
Date Posted |
October 31, 2003 |
Recall Status1 |
Terminated 3 on February 28, 2005 |
Recall Number |
Z-0075-04 |
Recall Event ID |
27417 |
PMA Number |
P980023/S8 |
Product Classification |
Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
|
Product |
Belos VR-T Implantable Cardioverter Defibrillator |
Code Information |
Serial Numbers: 78140141, 78140145, 78140146, 78140147, 78140148, 78140150, 78140151, 78140152. |
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 |
8 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 and Original Applicant = BIOTRONIK, INC.
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