Recall Z-1070-2015— TeraRecon, Inc.
Class II · Terminated
Class II FDA medical device recall by TeraRecon, Inc., initiated 2015-01-21, terminated 2015-09-30. It names one FDA 510(k) clearance: K121916. 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.. Reason: Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer..
- Recalling firm
- TeraRecon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-21
- Terminated
- 2015-09-30
- Firm location
- Foster City, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
Data sourced from openFDA. This site is unofficial and independent of the FDA.