EOS System X- ray beam Digital radiography system used in general… — Class II medical device recall Z-0529-2014
Terminated recall by EOS Imaging, reported 2014-01-15, distributed nationwide. EOS imaging discovered during production internal testing that the X-ray beam collimation set up by the operat
| Recall number | Z-0529-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EOS Imaging, Paris France, France |
| Recall initiated | 2013-11-07 |
| Classified | 2014-01-09 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2015-01-27 |
| Distributed | Nationwide (US) |
| Quantity | 22 eos |
Product
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Reason for recall
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.
Machine access
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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.