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U.S. Department of Health and Human Services

Class 2 Device Recall Phillips HeartStart MRx Monitor/Defribillator

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  Class 2 Device Recall Phillips HeartStart MRx Monitor/Defribillator see related information
Date Initiated by Firm February 18, 2014
Date Posted March 12, 2014
Recall Status1 Terminated 3 on September 17, 2020
Recall Number Z-1194-2014
Recall Event ID 67459
510(K)Number K051134  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Philips HeartStart MRx Monitor/Defibrillator
Models: M3535A and M3536A with Q-CPR Meter Option B08

The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Code Information MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587
Recalling Firm/
Manufacturer		 Philips Medical Systems, Inc.
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
978-687-1501
Manufacturer Reason
for Recall		 When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
FDA Determined
Cause 2		 Software Design Change
Action The firm, Philips Healthcare, sent an "URGENT -Medical Device Correction/Field Safety Notice" letter dated February 2014 on February 18, 2014 to its domestic and foreign customers. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the Action to be Taken by Customer/User section of the attached Field Safety Notice; to continue to use your HeartStart MRx without the Q-CPR Meter attached. If you choose to use the HeartStart MRx with the Q-CPR Meter attached and you observe that the Q CPR Meter is displaying the Do Not Touch the Patient icon at an unexpected time, follow the MRx Instructions for Use and remove the meter from the patient and continue CPR according to your organization's protocol. Philips plans to take to remedy the issue. Philips will provide a software upgrade free of charge. If you have questions regarding this notification or need any further information or support, please contact your local Philips representative or call at 1-800-722-9377.
Quantity in Commerce 6583 units
Distribution Worldwide distribution: US (nationwide) and to countries of: ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA ECUADOR EGYPT FINLAND FRANCE GERMANY HONG KONG INDIA INDONESIA IRELAND ISRAEL ITALY KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LIBYAN ARAB JAMAHIRIYA MALAYSIA MEXICO MOROCCO NETHERLANDS NORWAY OMAN PAKISTAN PHILIPPINES POLAND QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKEY UKRAINE UNITED ARAB EMIRATES and UNITED KINGDOM.
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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