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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 30, 2007
Date Posted July 04, 2007
Recall Status1 Terminated 3 on May 04, 2011
Recall Number Z-0887-2007
Recall Event ID 37692
Product Classification battery - Product Code MJK
Product Batteries used with the LIFEPAK 20 defibrillator/monitor
Code Information Battery Product Part Number: 3200497-000 Battery lot codes: prior to 0539; lot codes: 05 265 or 05 266
Recalling Firm/
Manufacturer		 Medtronic Emergency Response Systems, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
For Additional Information Contact James T. (Todd) Bandy
425-867-4514
Manufacturer Reason
for Recall		 Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.
FDA Determined
Cause 2		 Other
Action Firm sent letters on 03/30/2007 dated 03/2007 via certified return receipt to consignees with affected LIFEPAK 20 devices. The firm advised consignees to use the Operator's Checklist in the Operating Instructions to perform daily user tests and function checks while operating the defibrillator on battery power. In addition consignees are advised to replace their battery every 1 to 2 years.
Quantity in Commerce 3002
Distribution Distribution is worldwide. The device is designed to be used in healthcare provider facilities such as hospitals and clinic settings.
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.
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