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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Hearstart XL

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  Class 2 Device Recall Philips Hearstart XL see related information
Date Initiated by Firm February 14, 2014
Date Posted February 26, 2014
Recall Status1 Terminated 3 on June 16, 2016
Recall Number Z-1109-2014
Recall Event ID 67483
510(K)Number K051134  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Philips HeartStart XL, Defibrillator/Monitor
Model number M4735A


Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the M4735A HeartStart XL Defibrillator/Monitor is suitable for use by medical personnel trained in basic life support that includes the use of an AED
Code Information Serial numbers within the range:  US00101665 through US00608704 Units manufactured by Philips between May, 2013 and November, 2013.
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact Debbie Levasseur
978-659-4065
Manufacturer Reason
for Recall		 Philips HeartStart XL may experience a power board failure causing failure to defibrillate
FDA Determined
Cause 2		 Component design/selection
Action Philips Healthcare issued an Urgent Medical Device Correction notification/Field Safety Notice dated February 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed Philips Healthcare Representative will perform a hardware upgrade free of charge. Customers were instructed while awaiting the replacement power board for your device, you may continue to use the HeartStart XL. Identify a readily available backup defibrillator to use in the event the affected HeartStart XL fails to deliver therapy. If you need any further information or support concerning this issue, please contact your local Philips representative at 1-800-722-9377
Quantity in Commerce 5234 units
Distribution Worldwide Distribution and USA Nationwide and the countries of AUSTRALIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, ETHIOPIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, INDIA, INDONESIA, IRELAND, ITALY, JAPAN, KAZAKHSTAN, KOREA, REPUBLIC OF, MALAYSIA, MEXICO, MONACO, NEPAL, NETHERLANDS, PORTUGAL, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, and VIET NAM,
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 = PHILIPS MEDICAL SYSTEMS
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