Company: Radiometer America Inc.
Date of Enforcement Report 12/28/2016
Class lI:
PRODUCT
AQURE System Software Version 2.2.0Model #: 933-599UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599The 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
Recall Number Z-0899-2017
REASON
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
RECALLING FIRM/MANUFACTURER
Radiometer America Inc, Brea, CA.on 11/23/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7
DISTRIBUTION
Nationwide and Internationally
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