Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3...
FDA Device Recall #Z-0262-2016 — Class II — November 19, 2014
Recall Summary
| Recall Number | Z-0262-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 19, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems, Inc. |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 27,918 units |
Product Description
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
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.
Distribution Pattern
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.
Lot / 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.
Other Recalls from Philips Medical Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1643-2015 | Class II | Pinnacle3 Software Version 10.0, Model 4598002... | Apr 23, 2015 |
| Z-1555-2015 | Class II | Philips Healthcare DuraDiagnost X- Ray | Feb 9, 2015 |
| Z-1554-2015 | Class II | Philips Healthcare DigitalDiagnost System X-Ray | Feb 9, 2015 |
| Z-0346-2016 | Class II | Philips Healthcare Allura Xper Series: Allura ... | Feb 3, 2015 |
| Z-0350-2016 | Class II | Philips Healthcare INTEGRIS H5000F/Allura 9F ... | Feb 3, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.