FDAFDA · Food and drugs·Recall number Z-1194-2014
Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 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
Published March 19, 2014 · Recall initiated: February 18, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- Worldwide distribution: US (nationwide) and to countries of: ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA ECUADOR EGYPT FINLAND FRANCE GERMANY HONG KONG INDIA INDONESIA IRELAND ISRAEL ITALY KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LIBYAN ARAB JAMAHIRIYA MALAYSIA MEXICO MOROCCO NETHERLANDS NORWAY OMAN PAKISTAN PHILIPPINES POLAND QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKEY UKRAINE UNITED ARAB EMIRATES and UNITED KINGDOM.
- Lot
- MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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