Device Recall Phiips Medical Systems

  • Modelo / Serial
    Software versions: F.01.00 or F.01.01
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide -- USA, Canada, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FRANCE, GERMANY, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, KENYA, LATVIA, MALAYSIA, MEXICO, NEW ZEALAND, NORWAY, PHILIPPINES, REUNION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    Philips HeartStart MRx Defibrillator Monitor (M3535A/M3536A) with software (SW) versions F.01.00 or F.01.01 and with all of the following hardware options EtCO2, IP and Temp. || Used for the termination of ventricular tachycardia and ventricular fibrillation.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA