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.
FDA Recall Z-0899-2017 · Posted 2016-12-22
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Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2016-11-23
Date Terminated2017-02-07
Product Quantity7 total (2 in US)
Reason for Recall
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Firm Action
Radiomet4er sent a letter dated November 30, 2016, to all affected customers via email with a request for customers to complete a return form.
Customers/Users were advised to not use the "more" button to expand patient results when viewing them in the AQURE patient view. Customers/Users Radiometer Representative will contact them to schedule a visit of a remote session. During the visit or remote session the representative will run a script on the AQURE system, which serve to remove the misalighnment possibility.
It is noted in the letter to customers that expanding the results by using the More button will not affect the stored results.
If customers are not the end-user of the affected product ensure that the notification letter is distributed to the final end-user.
If any questions regarding the notification letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1.
For questions regarding this recall call 440-871-8900.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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