Class II — TeraRecon, Inc.
| Recalling firm | TERARECON, INC. |
|---|---|
| Registered facility | Terarecon, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer. |
| 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… |
| Quantity | 91 |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy. |
| Initiated | 2015-01-21 |
| Classified | 2015-02-09 |
| Terminated | 2015-09-30 |
| Recall number | Z-1070-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — TeraRecon, Inc. (Z-1070-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70426/
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