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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK

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  Class 2 Device Recall LIFEPAK see related information
Date Initiated by Firm May 05, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on January 06, 2005
Recall Number Z-0971-04
Recall Event ID 29027
510(K)Number K012274  
Product Classification Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
Product DC Power Adapter for use with the LIFEPAK 12 defibrillator/monitor.
Code Information Part numbers: VLP12-09-000031 through VLP12-09-000048. Serial numbers: 1563 through 5232 (non-contiguous)
Recalling Firm/
Manufacturer		 Medtronic Physio Control Corp
11811 Willows Rd NE
Redmond WA 98073
For Additional Information Contact John A. Parks
425-867-4681
Manufacturer Reason
for Recall		 The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor.
FDA Determined
Cause 2		 Other
Action On 5/5/04 the firm issued a letter to consignees advising of the problem and that a service representative will contact them regarding replacement of the DC Power Adapter.
Quantity in Commerce 1689
Distribution The firm distributed devices to medical facilities, fire departments (first responders).
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.
510(K) Database 510(K)s with Product Code = LDD and Original Applicant = MEDTRONIC PHYSIO-CONTROL CORP.
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