Reported Jan 15, 2014 · Terminated
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
EOS Imaging
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: EOS Imaging · 10 rue Mercoeur 4 Ieme Etage · Paris France · N/A
Is this the product you have?
- EOS System X- ray beam Digital radiography system used in general radiographic examinations.
- Lot codes and dates
- EOS System
- Amount recalled
- 22 EOS systems are installed in US
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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