FDA Devices recall · Reported February 18, 2015
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
Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
TeraRecon, Inc. recalled Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archivin… - a moderate-severity action.
Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archivin… was recalled by TeraRecon, Inc. in February 18, 2015. Reason: Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within th…. Check the official notice for the remedy. Verify recall #Z-1070-2015 with the FDA Devices before acting.
The recall
TeraRecon, Inc. issued this moderate-severity FDA Devices recall-Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within th….
- Moderate
- severity level
- 91 units
- affected scope
- Class II
- classification
- February 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1070-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1070-2015) was formally reported on February 18, 2015, with the manufacturer initiating the action on January 21, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. TeraRecon, Inc. is listed as the recalling firm, operating out of Foster City, CA. Federal records list the affected scope as 91.
The documented reason for this recall is: Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer. Distribution data in the federal record shows the product reached: Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1070-2015 |
| Date reported | February 18, 2015 |
| Date initiated | January 21, 2015 |
| Recalling firm | TeraRecon, Inc. |
| Firm location | Foster City, CA |
| Affected scope | 91 |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1070-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026