TeraRecon, Inc. recalls Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Fi…

Recall date

January 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1070-2015

FDA classification

Class II

Brand / firm

TeraRecon, Inc.

Sold / distributed

Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy.

Why it was recalled

Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.