FDA Device recall Z-1460-2015
EOS, Digital radiography system used in general radiographic examinations
- FDA Device
- Class II
- terminated
- Published 2015-05-13
On 2015-05-13 the FDA classified a Class II recall of EOS, Digital radiography system used in general radiographic examinations by Eos Imaging, citing when performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1460-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-17 |
| Published | 2015-05-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Eos Imaging |
| Distribution | CA, DE, FL, IL, IN, MN, MO, OH, PA |
Product
EOS, Digital radiography system used in general radiographic examinations.
Reason
When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.
Identifiers
| code_info | Model Number - 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-1460-2015%22
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