Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Aquarius iNtuition Client Viewer. Findings Workflow module Recalled by TeraRecon, Inc. Due to Software anomaly related to RECIST1.1 target lesion evaluation...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact TeraRecon, Inc. directly.
Affected Products
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.
Quantity: 91
Why Was This Recalled?
Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About TeraRecon, Inc.
TeraRecon, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report