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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare MRx

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  Class 2 Device Recall Philips Healthcare MRx see related information
Date Initiated by Firm February 18, 2014
Date Posted March 07, 2014
Recall Status1 Terminated 3 on September 11, 2020
Recall Number Z-1155-2014
Recall Event ID 67473
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
Product Philips HeartStart MRx Monitor/Defibrillator
Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
Code Information Serial numbers within the range: US00100204 to US00570921
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		 MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing
FDA Determined
Cause 2		 Component design/selection
Action Philips Healthcare issued and Urgent Medical Device Correction notification/Field Safety Notice on 02/18/14 to inform customers of the issue, Philips is asking customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction notification/Field Safety Notice: You can continue to use your MRx prior to receiving the hardware upgrade, provided that if you observe that the MRx is displaying a Red X in the Ready For Use (RFU) indicator\during automated tests, a failure has been detected that may prevent the delivery of a shock or pacing due to this issue. If this is observed you should turn the Therapy Knob to Monitor. An INOP message describing the failure is displayed. If needed, run an Operational Check for further information. If the condition persists, take the device out of use and call for service. Identify a readily available backup defibrillator to use in the event the affected HeartStart MRx fails to deliver therapy. Philips will perform a hardware upgrade (replace therapy boards) free of charge to be installed by a Philips Field Service Engineer. Contact your local Philips representative or call us at 1-800-722-9377.
Quantity in Commerce 3541 units
Distribution Nationwide Foreign: AUSTRIA BAHRAIN BELGIUM BRAZIL CANADA CHINA EGYPT ESTONIA FINLAND FRANCE GERMANY GHANA ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA MALAYSIA MEXICO MOZAMBIQUE MYANMAR (Burma) NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NORWAY PAKISTAN PERU POLAND PORTUGAL QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKMENISTAN UNITED ARAB EMIRATES UNITED KINGDOM 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.
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