FDA-Device2014-01-15Class II
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
EOS Imaging
Hazard
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.
Sold states
Nationwide Distribution
Affected count
22 EOS systems are installed in US
Manufactured in
10 rue Mercoeur 4 Ieme Etage, Paris France, France
Products
EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0529-2014Don't want to check this manually?
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