FDA Device recall Z-0529-2014
EOS System X- ray beam Digital radiography system used in general radiographic examinations
- FDA Device
- Class II
- terminated
- Published 2014-01-15
On 2014-01-15 the FDA classified a Class II recall of EOS System X- ray beam Digital radiography system used in general radiographic examinations by Eos Imaging, citing EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0529-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-07 |
| Published | 2014-01-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Eos Imaging |
| Distribution | US |
Product
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Reason
EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operator at the user interface of the acquisition workstation is different from the actual collimation of the X-ray beam operated by the EOS system during the X-ray acquisition.
Identifiers
| code_info | EOS System |
|---|
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-0529-2014%22
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