Recall Z-1070-2015 ยท LLZ System, Image Processing, Radiological
TeraRecon, Inc.
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 serve
| Date | Feb 9, 2015 (initiated Jan 21, 2015) |
| Status | Terminated |
| Reason | Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer. |
| Root cause | Software design |
| Action | Medical Device Correction letters were sent to all affected users on January 21, 2015 by both e-mail and physical mail - certified mail for us customers and FEDEX for international customers. |
| Quantity | 91 |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121916 | INTUITION Terarecon,Inc., Apr 2, 2013 |