Z-0899-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- November 23, 2016
- Termination Date
- February 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 total (2 in US)
Product Description
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.
Reason for Recall
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Distribution Pattern
Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
Code Information
UDI: (01)05700699335999(10)2.2.0