Aquarius iNtuition Client Viewer — Class II medical device recall Z-1070-2015
Terminated recall by TeraRecon, Inc., reported 2015-02-18, distributed nationwide. Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the
| Recall number | Z-1070-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TeraRecon, Inc., Foster City, CA, United States |
| Recall initiated | 2015-01-21 |
| Classified | 2015-02-09 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2015-09-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, DE, FR, IT |
| Quantity | 91 |
| Reason classes | software |
| Serial numbers | AQ-UH2305, AQ-UH3098, AQ-UH3663, AQ-UH4940, AQ-UH5116, AQ-UH5375, AQ-UH6467, AQ-UH6807, AQ-UH6915, AQ-UH7156, AQ-UH7183, AQ-UH7694, AQ-UH7704, AQ-UH7705, AQ-UH7706, AQ-UH7844, AQ-UH7848, AQ-UH7862, AQ-UH7863, AQ-UH7864, AQ-UH7874, AQ-UH7915, AQ-UH8040, AQ-UH8054, AQ-UH8100 and 66 more |
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 for recall
Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1070-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.