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U.S. Department of Health and Human Services

Class 2 Device Recall Defibrillator PCA wihtin the monitor of the LifeVest

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  Class 2 Device Recall Defibrillator PCA wihtin the monitor of the LifeVest see related information
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
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 = MVK and Original Applicant = ZOLL MANUFACTURING CORPORATION
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