Class 2 Device Recall Defibrillator

• Date Initiated by Firm: November 25, 2002
• Date Posted: December 18, 2002
• Recall Status: Terminated on May 03, 2012
• Recall Number: Z-0343-03
• Recall Event ID: 25131
• 510(K)Number: K001725 k010634 K021453
• Product Classification: Automated External Defibrillators (Non-Wearable) - Product Code MKJ
• Product: Philips HeartStart XL, Model M4735A Defibrillator/Monitor
• Code Information: S/N''s: US00100698 US00114827 US00114896 US00115000 US00104794 US00114828 US00114897 US00115001 US00111545 US00114829 US00114898 US00115002 US00114625 US00114830 US00114899 US00115003 US00114668 US00114831 US00114900 US00115004 US00114675 US00114832 US00114902 US00115005 US00114676 US00114836 US00114903 US00115006 US00114679 US00114848 US00114904 US00115008 US00114696 US00114850 US00114905 US00115009 US00114698 US00114851 US00114906 US00115010 US00114714 US00114852 US00114907 US00115012 US00114719 US00114857 US00114908 US00115015 US00114722 US00114859 US00114910 US00115018 US00114726 US00114860 US00114911 US00115019 US00114740 US00114861 US00114912 US00115020 US00114751 US00114862 US00114914 US00115021 US00114753 US00114863 US00114915 US00115022 US00114759 US00114864 US00114916 US00115024 US00114770 US00114865 US00114917 US00115025 US00114771 US00114866 US00114918 US00115027 US00114772 US00114868 US00114920 US00115028 US00114773 US00114869 US00114921 US00115029 US00114774 US00114870 US00114922 US00115030 US00114778 US00114871 US00114924 US00115031 US00114780 US00114872 US00114925 US00115032 US00114782 US00114873 US00114926 US00114788 US00114874 US00114927 US00114790 US00114875 US00114928 US00114792 US00114878 US00114929 US00114793 US00114879 US00114930 US00114794 US00114880 US00114931 US00114797 US00114881 US00114932 US00114798 US00114882 US00114934 US00114799 US00114883 US00114935 US00114800 US00114884 US00114959 US00114801 US00114885 US00114962 US00114803 US00114886 US00114974 US00114806 US00114887 US00114980 US00114809 US00114889 US00114981 US00114814 US00114890 US00114983 US00114817 US00114891 US00114992 US00114818 US00114892 US00114993 US00114821 US00114893 US00114994 US00114824 US00114894 US00114997 US00114825 US00114895 US00114998
• Recalling Firm/ Manufacturer: Philips Medical Systems, Inc. Cardiac & Monitoring Systems; 3000 Minuteman Road; Andover MA 01810
• For Additional Information Contact: Brenda Getchell; 978-659 Ext. 2134
• Manufacturer Reason for Recall: Defective energy switch may cause Defibrillator to turn off or charge to a different energy level than was selected.
• FDA Determined Cause: Other
• Action: On 11/25/02 Philips notified customers by letter and requested users to identify the device and use an alternate defibrillator. Philips systems representatives will repair the device in the field. Instructions, titled: 'Risk Mitigation Procedure,' were provided if the unit cannot be pulled from service.
• Quantity in Commerce: 260 units
• Distribution: AL, AZ, CA, CT, DE, FL, IL , IN, LA, NE, NY, PA, TX Nationwide Foreign: Canada, Algeria, Belgium, France, Great Britain, Ireland, Israel, Italy, Lebanon, Spain, Sweden, Hong Kong, Philippines, Singapore, Taiwan, China, Japan,Trinadad
• 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 = AGILENT TECHNOLOGIES, INC.; 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS