Company: EOS Imaging
Date of Enforcement Report:1/15/2014
Class lI:
PRODUCT
EOS System X- ray beam Digital radiography system used in general radiographic examinations. Recall Number Z-0529-2014
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.
RECALLING FIRM/MANUFACTURER
EOS Imaging, Paris, France on 11/7/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
22 EOS systems are installed in US
DISTRIBUTION
Nationwide
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