FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalo
FDA device recall Z-1049-2015 · posted 2015-02-04 · Terminated
Recall details
- Recalling firm
- Carl Zeiss Meditec AG
- Reason for recall
- Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to misinterpretation of the optical coherence tomography (OCT) data.
- Action taken
- Important Field Corrective Action for Forum Viewer letters were sent to all affected US customers on January 22, 2015 by certified mail.
- Root cause
- Software in the Use Environment
- Status
- Terminated
- Product code
- NFJ
- Quantity affected
- 985
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-01-22
- Date posted
- 2015-02-04
- Date terminated
- 2016-03-04
- Location
- Jena, Germany
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH (K122938) | Carl Zeiss Meditec, AG | 2012-11-02 |