Device Recall Philips IntelliVue Information Center iX (release A.00, A.01, and A.02)

  • Modelo / Serial
    Software systems Revision A.02.05 or lower
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and countries: AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CANADA, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, HUNGARY, ICELAND, INDIA, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, LUXEMBOURG, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIAN FEDERATION, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Descripción del producto
    Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: || 866023 IntelliVue Info Center iX || 866024 PIIC iX Upgrade || 866117 PIIC Classic Upgrade || The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. || An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Philips Medical Systems, Inc., 3000 Minuteman Rd, Andover MA 01810-1032
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA