Class 2 Device Recall Philips

• Date Initiated by Firm: December 15, 2004
• Date Posted: December 21, 2004
• Recall Status: Terminated on February 02, 2016
• Recall Number: Z-0341-05
• Recall Event ID: 30666
• 510(K)Number: K031187
• Product Classification: Automated External Defibrillators (Non-Wearable) - Product Code MKJ
• Product: Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use) , M3536A (EMS Use)
• Code Information: Software versions A.02.00 and lower
• FEI Number: 1218950
• Recalling Firm/ Manufacturer: Philips Medical Systems; 3000 Minuteman Rd; Andover MA 01810-1032
• For Additional Information Contact: Brenda Getchell; 978-659-2134
• Manufacturer Reason for Recall: In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy
• FDA Determined Cause: Other
• Action: Philips notified customers on 12/13/04 by letter. Users are provided with action required to Mitigate Risk' until the correction is made by a Systems representative.
• Quantity in Commerce: 2520 units
• Distribution: Nationwide Foreign:Canada, Austria, Australlia, Belgium, China, Denmark, Finland, France, Germany, Israel, Italy,Kuwait, Latvia, Lebannon, Libya, Netherland,Norway, Portugal, Qatar, Russia, Singapore,South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand,Tunisia, UK, United Arab Emirates, Yemen
• 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