Z-0899-2017Class II

AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599...

Name: Z-0899-2017 AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599...
Creator: Radiometer America Inc
Published: 2016-11-23
License: https://open.fda.gov/license/

Radiometer America, Inc / initiated 2016-11-23 / Terminated / root cause: software

FDA source

Radiometer America Inc began a recall of 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... on 2016-11-23. FDA classified it as Class II and gives the reason as "Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0899-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-23
Posted: 2016-12-22
Terminated: 2017-02-07
Recalling firm: Radiometer America, Inc
Product: 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.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 7 total (2 in US)
Distribution: Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
Product codes and lots: UDI: (01)05700699335999(10)2.2.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0899-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0899-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

Product code CHL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)