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U.S. Department of Health and Human Services

Class 2 Device Recall HeartStart MRx Defibrillator

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  Class 2 Device Recall HeartStart MRx Defibrillator see related information
Date Initiated by Firm April 08, 2013
Date Posted April 29, 2013
Recall Status1 Open3, Classified
Recall Number Z-1189-2013
Recall Event ID 64860
510(K)Number K051134  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6.

The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Code Information Serial numbers ranging from US00100100 to US00565942

Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6.
Recalling Firm/
Philips Healthcare Inc.
3000 Minuteman Road
Andover MA 01810
For Additional Information Contact
Manufacturer Reason
for Recall
Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode.
FDA Determined
Cause 2
Software design
Action The firm, Philips Healthcare, sent an "Field Safety Notice-URGENT - MEDICAL DEVICE RECALL" letter dated April 2013 to its customers. The letter describes the product, problem and actions to be taken. In addition, letter provides instructions for using the MRx prior to receiving the software upgrade and informs the customer that Philips is initiating a correction consisting of a software upgrade for all units affected. The customers were instructed to follow the "ACTION TO BE TAKEN BY CUSTOMER/USER" section of the Field Safety Notice; send a copy of the attached package including customer letter and Field Safety Notice to any customer to whom you have distributed one of the affected device; and provide your local Philips organization with the names and addresses of customers to whom you have sold affected devices, so that arrangements can be made to perform the software updates. Should you have any questions or concerns about this device correction, please contact your local Philips representative at 1-800-722-9377. Philips updated the Field Safety Notice dated May 2013 to users who have not had the software upgrade performed. It provided additional information in the "Problem Description" and "Action to Be Taken By Customer/User".
Quantity in Commerce 64972
Distribution Worldwide distribution: USA (nationwide) and countries of: Afghanistan, Albania, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia and Herzegowina, Brazil, Brunei Darussalam, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of, Kuwait, Laos, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Malta, Mexico, Mongolia, Morocco, Namibia, Nepal, Netherlands (Antilles), New Caledonia, New Zealand, Nicaragua, Nigera, Norway, Oman, Pakistan, Palestine, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Puerto, Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, SRI Lanka, Sweden, Switzerland, Taiwan (Province of China), Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Veit Nam, and 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS