Device Recall Spacelabs Healthcare G2 Clinical Access CD

  • Modelo / Serial
    Two G2 Clinical Access CD part numbers are affected: PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10.  Serial numbers distributed in the US: "040-1565-10" and "063-1829-11".   Serial number distributed outside the US: "063-1829-11".
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- USA (nationwide) including the states of Alabama, Florida, Georgia, Louisiana, Missouri, New York, South Carolina, Tennessee, Texas and Wyoming, and the countries of Australia, Canada, Czechoslovakia, China, Colombia, France, Great Britain, Italy, Netherlands, Poland, Saudi Arabia, and Turkey.
  • Descripción del producto
    Spacelabs Healthcare G2 Clinical Access Mislabeled CDs for PN: 063-1829-11 Rev A and Update Kit, PN: 040-1565-10. || Used for installing ICS G2 Clinical Access software onto hospital personal computers.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Spacelabs Healthcare, Llc, 35301 Se Center St, Snoqualmie WA 98065-9216
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA