Class 2 Device Recall LIFEPAK

• Date Initiated by Firm: May 05, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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)
• FEI Number: 3015876
• 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: 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