Device Recall CSM1901

  • Modelo / Serial
    Lot/Unit Codes: G9 Serial Number: 230 (UDI: 01049319211121682100230) Serial Number: 232 (UDI: 01049319211121682100232)  Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-6201A (PU-621RA) with version 01-06, 02-10, or 02-40 software.  Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-9701A (MU-971RA) with version 01-89 or lower.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Korea, Malaysia, Singapore, Thailand
  • Descripción del producto
    Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Nihon Kohden America Inc, 15353 Barranca Pkwy, Irvine CA 92618-2216
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA