FDA Device recall Z-0580-2014
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is…
- FDA Device
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is… by Eos Imaging, citing error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0580-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-29 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Eos Imaging |
| Distribution | US |
Product
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and digital processing of two 3D x-ray images.
Reason
Error copying information to the clinical file and to the report when two 3D models are opened simultaneously on the sterEOS workstation
Identifiers
| code_info | Software versions: 1.3, 1.4 and 1.5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0580-2014%22
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