Reported Feb 18, 2015 · Terminated
Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System;…
TeraRecon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TeraRecon, Inc. · 4000 E 3rd Ave Ste 200 · Foster City, CA · 94404-4805
Is this the product you have?
- 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.
- Lot codes and dates
- Serial numbers
91 of 91 codes
AQ-UH6467AQ-UH7694AQ-UH8703AQ-UN5993AQ-UH8380AQ-UH8481AQ-UH8510AQ-UH8511AQ-UN5272AQ-UH7183AQ-UH5375AQ-UN5266AQ-UH6807AQ-UH6915AQ-UH8676AQ-UN5143AQ-UH8516AQ-UN5234AQ-UH7704AQ-UH7705AQ-UH7706AQ-UH8197AQ-UH8269AQ-UN5247AQ-UN5086AQ-UN5256AQ-UH8184AQ-UH8454AQ-UH8502AQ-UH8614AQ-UH8610AQ-UH8609AQ-UN5274AQ-UN5273AQ-UH8603AQ-UH8597AQ-UH8598AQ-UN5163AQ-UH3663AQ-UH8309AQ-UN5268AQ-UN5269AQ-UH8574AQ-UH8575AQ-UH8576AQ-UH8365AQ-UN5250AQ-UH7862AQ-UH7863AQ-UH7864AQ-UH8617AQ-UH8551AQ-UH8565AQ-UH8586AQ-UH8585AQ-UN5267AQ-UH8541AQ-UN5261AQ-UH8294AQ-UN5260
- Serial numbers
- Amount recalled
- 91
Where it was sold
- Nationwide
Why it was recalled
Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
This product could cause temporary or reversible health problems — stop using it.
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