Class II — Eos Imaging Inc
| Recalling firm | EOS imaging |
|---|---|
| Registered facility | EOS imaging (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | EOS, Digital radiography system used in general radiographic examinations. |
| Quantity | 13 units installed in US |
| Distribution | US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL. |
| Initiated | 2015-02-17 |
| Classified | 2015-05-05 |
| Terminated | 2017-05-31 |
| Recall number | Z-1460-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Eos Imaging Inc (Z-1460-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70732/
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