Device Recall AQURE, Software version 2.3.0 and 2.3.1

  • Model / Serial
    Version 2.3.0 and 2.3.1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states to Georgia and Wisconsin.
  • Product Description
    AQURE, Software version 2.3.0 and 2.3.1 || Product Usage: || The AQURE system is intended to let allow the management of 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 the user 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

Manufacturer

  • Manufacturer Address
    Radiometer Medical ApS, Akandevej 21, Bronshoj Denmark
  • Manufacturer Parent Company (2017)
  • Source
    USFDA