FDAFDA · Food and drugs·Recall number Z-1155-2014
Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491
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
MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems, Inc.
- Distributor
- Nationwide Foreign: AUSTRIA BAHRAIN BELGIUM BRAZIL CANADA CHINA EGYPT ESTONIA FINLAND FRANCE GERMANY GHANA ICELAND INDIA INDONESIA IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KOREA, REPUBLIC OF LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA MALAYSIA MEXICO MOZAMBIQUE MYANMAR (Burma) NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NORWAY PAKISTAN PERU POLAND PORTUGAL QATAR RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SOUTH AFRICA SPAIN SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA THAILAND TURKMENISTAN UNITED ARAB EMIRATES UNITED KINGDOM VIET NAM
- Lot
- Serial numbers within the range: US00100204 to US00570921
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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