Date Initiated by Firm | October 21, 2008 |
Date Posted | January 28, 2009 |
Recall Status1 |
Terminated 3 on November 04, 2009 |
Recall Number | Z-0883-2009 |
Recall Event ID |
50119 |
PMA Number | P010030 |
Product Classification |
wearable, defibrillator, automatic, external - Product Code MVK
|
Product | Monitor portion of the LifeVest device - specifically the Defibrillator printed circuit assembly (PCA) within the monitor.
The LifeVest is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. |
Code Information |
model numbers WCD3000 and WCD3100 |
Recalling Firm/ Manufacturer |
Zoll Lifecor Corporation 121 Freeport Rd Pittsburgh PA 15238-3411
|
For Additional Information Contact | Jason Whiting 412-826-9300 |
Manufacturer Reason for Recall | The charging circuit will not shut down properly. |
FDA Determined Cause 2 | Component design/selection |
Action | Physicians with active patients were notified of the product removal by letter via first-class mail dated 10/21/2008. The letter describes the problem and the potential risk. For additional information, contact ZOLL Lifecor Corporation at 1.800.543.3267. |
Quantity in Commerce | 1685 units |
Distribution | Nationwide. OUS: Germany, United Kingdom, Italy, and France. |
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 = MVK
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