Company: Eos Imaging Inc.
Date of Enforcement Report: 5/13/2015
Class lI:
PRODUCT
EOS, Digital radiography system used in general radiographic examinations.
Recall Number Z-1460-2015
REASON
When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed. Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.
RECALLING FIRM/MANUFACTURER
Eos Imaging Inc, Cambridge, MA on 2/17/2015 Voluntary: Firm Initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
13
DISTRIBUTION
US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
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