Class 2 Device Recall LIFEPAK 12

• Date Initiated by Firm: January 27, 2003
• Date Posted: February 05, 2003
• Recall Status: Terminated on February 24, 2004
• Recall Number: Z-0542-03
• Recall Event ID: 25289
• 510(K)Number: K973486 K990338 K991910 K002445 K010918
• Product Classification: Automated External Defibrillators (Non-Wearable) - Product Code MKJ
• Product: LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to externally pace, manually defibrillate, or automatically analyze and if necessary, defibrillate a patient through therapy cables with disposable electrodes, standard paddles, or internal handle cables. Product is labeled with ''Medtronic Physio-Control, Redmond, WA''
• Code Information: Each unit is given a unique serial number. All LIFEPAK 12 units are affected.
• Recalling Firm/ Manufacturer: Medtronic Physio Control Corp; 11811 Willows Rd NE; Redmond WA 98073
• Manufacturer Reason for Recall: Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.
• FDA Determined Cause: Other
• Action: Consignees were notified of recall action by letter dated January 2003. Letter advised consignees to follow recommendations for periodic inspections and to test device to verify readiness. A few weeks later the consignees were sent a correction letter along with user installable shields.
• Quantity in Commerce: domestic: 30,575 foreign: 15,467
• Distribution: Worldwide distribution, including government/military accounts.
• 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 = MKJ and Original Applicant = MEDTRONIC PHYSIO-CONTROL CORP.; 510(K)s with Product Code = MKJ and Original Applicant = PHYSIO-CONTROL CORP.