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Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M...

FDA Device Recall #Z-0613-2014 — Class II — April 10, 2013

Recall Summary

Recall Number Z-0613-2014
Classification Class II — Moderate risk
Date Initiated April 10, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Medical Systems, Inc.
Location Andover, MA
Product Type Devices
Quantity 64,972

Product Description

Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 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

Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to the following countries: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GERMANY 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 MACAU MACEDONIA MALAYSIA MALTA MEXICO MONGOLIA MOROCCO NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA 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

Serial numbers ranging: From US00100100 to US00210461

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 physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

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.

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