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TeraRecon, Inc. recalls Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; F
Recalled February 18, 2015 · FDA recall Z-1070-2015 · TeraRecon
Hazard
Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer. · FDA Class II
Units
91
Sold at
Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy.
Description
Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
Product
Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and visualization functions, including basic features and advanced post processing modules. The system can be configured as a server with some, all, or none of its optional features disabled. The intended use of the device is to provide solutions to various medical image-analysis and viewing problems, which come about as modalities generate more and more images. It also supports image distribution over networks, and is DICOM compliant.
Manufacturer(s)
TeraRecon, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →