Class 2 Device Recall LIFEPAK 12 DEFIBRILLATOR/MONITOR

• Date Initiated by Firm: March 31, 2009
• Date Posted: February 22, 2010
• Recall Status: Terminated on August 08, 2013
• Recall Number: Z-0811-2010
• Recall Event ID: 54005
• 510(K)Number: K063510
• Product Classification: automated external defibrillators (non-wearable) - Product Code MKJ
• Product: Biphasic LIFEPAK 12 defibrillator / monitor.
• Code Information: Part Number: LP12, VLP12-02-(various dash numbers). 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37661630.
• FEI Number: 3015876
• Recalling Firm/ Manufacturer: Physio Control, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: 425-867-4000
• Manufacturer Reason for Recall: Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contribute to the death of a viable patient.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Consignees were sent a notification letter dated March 2009 that explained firm representatives would follow up with each customer within 30 days to arrange an update to affected devices. Affected Biphasic PCBAs will be replaced. Customers advised to keep the devices in use and to continue to perform daily User Test.
• Quantity in Commerce: 1718
• Distribution: Distributed domestically and internationally to hospitals, clinics, etc. Foreign distribution to the following countries: Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands, and Puerto Rico.
• 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