Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536...
FDA Device Recall #Z-1110-2014 — Class II — February 4, 2014
Recall Summary
| Recall Number | Z-1110-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 4, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems, Inc. |
| Location | Andover, MA |
| Product Type | Devices |
| Quantity | 58466 units |
Product Description
Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
Reason for Recall
HeartStart MRx Defibrillator Monitor therapy connection could experience accelerated wear causing risk for patients and/or caregivers
Distribution Pattern
Worldwide Distribution: USA (nationwide) and to countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND France GERMANY GHANA 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 MACEDONIA MALAYSIA MEXICO MONGOLIA MOROCCO MOZAMBIQUE MYANMAR (Burma)¿ NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA 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, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY TURKMENISTAN UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM YEMEN
Lot / Code Information
MRx devices and serial numbers within the following ranges: M3535A Serial Numbers: USD0100104 - USD0572207; M3536A Serial Numbers: USD0100902 - USD0543688; M3536J Serial Numbers USD0209838 - USD0332675; M3536M Serial Numbers: USD0500002 - USD0500009; M3536MC Serial Nukmbers: USD0500002 - USD0500028
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-0348-2016 | Class II | Philips Healthcare INTEGRIS cardio system Mod... | 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.