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EOS Imaging recalls EOS System X- ray beam Digital radiography system used in general radiographic examinations.
Recalled January 15, 2014 · FDA recall Z-0529-2014 · 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. · FDA Class II
Units
22 EOS systems are installed in US
Sold at
Nationwide Distribution
Description
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.
Manufacturer(s)
EOS Imaging
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →