Dec

2016

AQURE System Software Version 2.2 Cl II

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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AQURE System Software Version 2.2 Cl II

Amy Sellers

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