Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0899-2017

November 23, 2016

Class II

Product summary

Firm
Radiometer America Inc
Event
Event 75836
Status
Terminated
Classification
Class II
Quantity
7 total (2 in US)
Official record key
device-enforcement:Z-0899-2017

Official wording

Reason: Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.

Code information: UDI: (01)05700699335999(10)2.2.0

Distribution pattern: Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Design error