Class 2 Device Recall LIFEPAK EXPRESS

• Date Initiated by Firm: January 31, 2006
• Date Posted: February 23, 2006
• Recall Status: Terminated on January 17, 2011
• Recall Number: Z-0548-06
• Recall Event ID: 34534
• Product Classification: Automated External Defibrillators (Non-Wearable) - Product Code MKJ
• Product: LIFEPAK EXPRESS defibrillator
• Code Information: Part number 3202177-00 through -002 Serial numbers listed above with the CR Plus
• Recalling Firm/ Manufacturer: Medtronic Emergency Response Systems, Inc.; 11811 Willows Rd Ne; Redmond WA 98052-2003
• For Additional Information Contact: Todd Bandy, CBET; 425-867-4514
• Manufacturer Reason for Recall: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 1/31/06 the firm sent a letter flagged URGENT-MEDICAL DEVICE RECALL to their customers via certified return receipt. The letter advised customers of the problem and requested the customers inspect their units at least weekly. The customers are provided additional guidance if they see certain symbols as described in the letter. The firm''s service personnel will visit the customers, remove and replace units.
• Quantity in Commerce: 20,525 devices total - CR Plus and LIFEPAK Express
• Distribution: Units were distributed worldwide to public access environments.
• 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.