Device Recall Radiometer, ABL 80, ABL90, ABL 800 FLEX Blood Gas analyzers with AQURE Software version 2.2.0

  • Modelo / Serial
    UDI: (01)05700699335999(10)2.2.0
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
  • Descripción del producto
    AQURE System || Software Version 2.2.0 || Model #: 933-599 || UDI: (01)05700699335999(10)2.2.0 || Catalog number: 933-599 || The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Radiometer America Inc, 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA