FDAFDA · Alimentos y medicamentos·N.º oficial 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
Publicado el 19 de marzo de 2014 · Inicio del retiro: 18 de febrero de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Philips Medical Systems, Inc.
- Distribuidor
- 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.
- Lote
- MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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