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U.S. Department of Health and Human Services

Class 2 Device Recall AQURE, Software version 2.3.0 and 2.3.1

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  Class 2 Device Recall AQURE, Software version 2.3.0 and 2.3.1 see related information
Date Initiated by Firm February 27, 2018
Date Posted March 14, 2018
Recall Status1 Terminated 3 on March 20, 2019
Recall Number Z-1582-2018
Recall Event ID 79411
510(K)Number K142898  K151856  K130144  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product 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.
Code Information Version 2.3.0 and 2.3.1
Recalling Firm/
Radiometer Medical ApS
Akandevej 21
Bronshoj Denmark
For Additional Information Contact
800-736-0600 Ext. 1
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 2
Distribution US Nationwide Distribution in the states to Georgia and Wisconsin.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = RADIOMETER MEDICAL APS
510(K)s with Product Code = CHL and Original Applicant = Radiometer Medical Aps.
510(K)s with Product Code = CHL and Original Applicant = SENDX MEDICAL INC.