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Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M35...

FDA Device Recall #Z-1797-2013 — Class II — June 19, 2013

Recall Summary

Recall Number Z-1797-2013
Classification Class II — Moderate risk
Date Initiated June 19, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Philips Healthcare Inc.
Location Andover, MA
Product Type Devices
Quantity 66,150 units

Product Description

Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 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

The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and 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 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 UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM and YEMEN.

Lot / Code Information

Serial numbers ranging from: US00100100 to US00567299 (serial numbers of the HeartStart MRx monitor/defibrillator are printed on the primary label on the back of the MRx in battery bay B)

Other Recalls from Philips Healthcare Inc.

Recall # Classification Product Date
Z-2059-2013 Class II Philips Easy Upgrade DR, Code No: 712086 Thi... Aug 8, 2013
Z-1780-2013 Class II Radiohead Access Point 1.4 GHz Radiohead Access... Jul 8, 2013
Z-1964-2013 Class II Philips Healthcare MobileDiagnostwDR system. M... Jun 11, 2013
Z-1189-2013 Class II HeartStart MRx Monitor/Defribillator; Product C... Apr 8, 2013
Z-1783-2014 Class II Philips IntellVue Info Center iX 866023; PIIC i... Mar 5, 2013

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.

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