Class 2 Device Recall

• Date Initiated by Firm: May 23, 2003
• Date Posted: June 12, 2003
• Recall Status: Terminated on February 24, 2004
• Recall Number: Z-0940-03
• Recall Event ID: 26358
• 510(K)Number: K011144
• Product Classification: Automated External Defibrillators (Non-Wearable) - Product Code MKJ
• Product: LIFEPAK CR Plus defibrillator
• Code Information: All serial numbers below 31058753
• Recalling Firm/ Manufacturer: Medtronic Physio Control Corp; 11811 Willows Rd NE; Redmond WA 98073
• For Additional Information Contact: 425-867-4000
• Manufacturer Reason for Recall: Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
• FDA Determined Cause: Other
• Action: On 5/23/03, the firm issued a recall letter to customers advising of the malfunctions and instructions to check the device to assure it is ready for use. Service representatives will visit the customer sites and replace the flex circuit in all affected devices.
• Quantity in Commerce: 7095 devices
• Distribution: The firm distributed units worldwide. Foreign distribution includes Australia, Canada, Costa Rica, Hong Kong, India, Israel, Jamaica, Netherlands, New Zealand, Saudi Arabia, South Africa, Uruguay.
• 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.