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U.S. Department of Health and Human Services

Class 2 Device Recall LIFEPAK 20

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  Class 2 Device Recall LIFEPAK 20 see related information
Date Initiated by Firm June 17, 2005
Date Posted July 13, 2005
Recall Status1 Terminated 3 on May 06, 2006
Recall Number Z-0984-05
Recall Event ID 32492
510(K)Number K012274  
Product Classification Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
Product LIFEPAK 20 defbrillator/monitor
Code Information Various, noncontiguous serial numbers. Part numbers: 3202487-xxxd and 3202488-xxx.
Recalling Firm/
Medtronic Emergency Response Systems, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
Manufacturer Reason
for Recall
The defibrillator may not operate if the device is turned on during an AC Loss Alert.
FDA Determined
Cause 2
Action On 6/17/05 the firm issued a medical device correction letter to customers advising of the problem, explained what to do if the situation occurs, and that a service representative will visit and install new software.
Quantity in Commerce 3924 units
Distribution Devices were distributed to hospitals and medical centers worldwide.
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.