Radiometer America Inc: Medical Device Recalls in 2016

According to to data from the FDA, there were 3 medical device recalls made by Radiometer America Inc in 2016. See the details of the recalls below.

You can see similar recalls for other firms.

• TCM CombiM Modules 903-111
• AQURE System; Model Number: 933-599. The AQURE System manages blood gas and immunoassay analyzers.
• 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.