Recall Z-0899-2017 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Radiometer America Inc
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 i
| Date | Dec 22, 2016 (initiated Nov 23, 2016) |
| Status | Terminated |
| Reason | Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value. |
| 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 |
| Quantity | 7 total (2 in US) |
| Distribution | Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates. |
| FDA record | Open on fda.gov |