Class II — EOS Imaging
| Recalling firm | EOS imaging |
|---|---|
| Registered facility | EOS imaging (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | EOS System X- ray beam Digital radiography system used in general radiographic examinations. |
| Quantity | 22 EOS systems are installed in US |
| Distribution | Nationwide Distribution |
| Initiated | 2013-11-07 |
| Classified | 2014-01-09 |
| Terminated | 2015-01-27 |
| Recall number | Z-0529-2014 |
| 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 (Z-0529-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66833/
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