| Class 2 Device Recall Philips Healthcare | |
Date Initiated by Firm | November 19, 2014 |
Date Posted | November 10, 2015 |
Recall Status1 |
Terminated 3 on February 20, 2018 |
Recall Number | Z-0262-2016 |
Recall Event ID |
69714 |
510(K)Number | K031187 K040404 K051134 K061707 K062233 |
Product Classification |
Automated external defibrillators (non-wearable) - Product Code MKJ
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Product | Philips HeartStart MRx Monitor/Defibrillator
Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5
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 |
Model M3535A: US00100100 to US00552845; Model M3536A: US00100902 to US00552848; Model M3536M: US00500002 to US00501201; Model M3536MC: US00500001 to US00500087; Model M3536M4: US00500003, US00500004, US00552673, US00552678, US00552679; Model M3536M5: US00500001 to US00552801 Note: Not every serial number within the listed ranges are affected by this Medical Device Correction. Philips HeartStart MRx Monitors/Defibrillators (1) within the identified serial number range AND (2) meeting one or both of the conditions below are affected by the issue. Condition #1: Device has EtCO2 Option. Devices with the EtCO2 option are affected. To determine if an MRx has the EtCO2 option, press the Menu Select button to open the Main Menu. Use the Navigation and Menu Select buttons to select Other, followed by Print Device Info. Devices with EtCO2 option have etCO2 printed under Options on the printed strip. Condition #2: Device has Old Cap Plate. Devices with a paddle tray or the new cap plate are not affected. New Cap Plate (NOT affected) positions the handle in the middle of the cap plate and covers the entire top of the MRx. |
Recalling Firm/ Manufacturer |
Philips Medical Systems, Inc. 3000 Minuteman Rd Andover MA 01810-1032
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For Additional Information Contact | 978-687-1501 |
Manufacturer Reason for Recall | MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tidal carbon dioxide (EtCO2) monitoring on MRx Monitor/Defibrillators can be pushed into the MRx housing, making it inaccessible. 2. The handle can separate from the MRx housing due to breakage of mounts on the rear case. |
FDA Determined Cause 2 | Device Design |
Action | Philips Heatlhcare issued on November 19, 2014, an Urgent Medical Device Correction notification/Field Safety Notice. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.
A software upgrade will be provided free of charge for all units affected by one or more of these issues. A Philips Healthcare representative will contact customers with affected devices to arrange for installation of the upgrade.
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 you follow the steps given.
For questions regarding this recall call 978-687-1501
Customers with questions were instructed to contact their local Philips representative. |
Quantity in Commerce | 27,918 units |
Distribution | Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CROATIA (local name: Hrvatska), CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NETHERLAND ANTILLES, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UGANDA, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, AND YEMEN. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = MKJ 510(K)s with Product Code = MKJ 510(K)s with Product Code = MKJ
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