Class 2 Device Recall LIFEPAK 20

• Date Initiated by Firm: June 17, 2005
• Date Posted: July 13, 2005
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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.