EOS — Class II medical device recall Z-1460-2015
Terminated recall by Eos Imaging Inc, reported 2015-05-13, distributed in CA, DE, FL, IL, IN, MN, MO, OH…. When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed.
| Recall number | Z-1460-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Eos Imaging Inc, Cambridge, MA, United States |
| Recall initiated | 2015-02-17 |
| Classified | 2015-05-05 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2017-05-31 |
| Distributed | CA, DE, FL, IL, IN, MN, MO, OH, PA |
| Quantity | 13 units |
Product
EOS, Digital radiography system used in general radiographic examinations.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1460-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.