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U.S. Department of Health and Human Services

Class 3 Device Recall Battery Pack portion of the LifeVest device

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  Class 3 Device Recall Battery Pack portion of the LifeVest device see related information
Date Initiated by Firm September 14, 2007
Date Posted October 18, 2007
Recall Status1 Terminated 3 on June 13, 2008
Recall Number Z-0061-2008
Recall Event ID 44942
PMA Number P010030 
Product Classification battery - Product Code MVK
Product Battery Pack portion of the LifeVest device. The LifeVest is a wearable cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA).
Code Information Product number 10A0894-A01. Serial numbers 71000101 through 71003176.
Recalling Firm/
Manufacturer		 Zoll Lifecor Corporation
121 Freeport Rd
Pittsburgh PA 15238-3411
For Additional Information Contact Walt Welch
412-826-9300
Manufacturer Reason
for Recall		 Possible malfunction of the battery pack. A significant electrostatic discharge (ESD) can cause the battery pack to malfunction. The malfunction causes the battery pack to discharge more rapidly and prevents the pack from recharging.
FDA Determined
Cause 2		 Device Design
Action Patients currently using the LifeVest should continue to do so while the product removal is underway. Advisory notices will be sent via first class mail 9/14/2007 to all active patients using the LifeVest device. Product replacements began on 8/31/07 by shipping out revised battery packs for new patient use. Shipments of new battery packs will continue based on production capacity and material availability. Any patients expected to be using the device longer than 5 months will be provided with 2 replacement Battery Packs. They will be instructed to return their existing packs in the same shipping box.
Quantity in Commerce 2006 packs
Distribution The product was shipped nationwide to patients. The product was also shipped to distributors in Germany, United Kingdom, Italy, Spain, France, and Denmark.
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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