Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Fin
FDA device recall Z-1070-2015 · posted 2015-02-09 · Terminated
Recall details
- Recalling firm
- TeraRecon, Inc.
- Reason for recall
- Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 91
- Distribution
- Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy.
- Date initiated
- 2015-01-21
- Date posted
- 2015-02-09
- Date terminated
- 2015-09-30
- Location
- Foster City, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITION (K121916) | Terarecon,Inc. | 2013-04-02 |