Events

Recall of Device Recall AQURE, Software version 2.3.0 and 2.3.1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Radiometer Medical ApS.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79411
  • Event Risk Class
    Class 2
  • Event Number
    Z-1582-2018
  • Event Initiated Date
    2018-02-27
  • Event Date Posted
    2018-03-14
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162251
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Reason
    There is a potential problem relating to the aqure system, versions 2.3.0 and 2.3.1, that may result in patient mix-up.
  • Action
    Radiometer Medical sent a Notification letter dated February 27, 2018 to customers. The letter identified the affected product, problem and actions to be taken For questions contact your Radiometer representative.

Device

Device Recall AQURE, Software version 2.3.0 and 2.3.1
  • Model / Serial
    Version 2.3.0 and 2.3.1
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • 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
    Radiometer Medical ApS

Manufacturer

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