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Eos Imaging Inc recalls EOS, Digital radiography system used in general radiographic examinations.
Recalled May 13, 2015 · FDA recall Z-1460-2015 · Eos Imaging
Hazard
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. · FDA Class II
Units
13 units installed in US
Sold at
US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
Description
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.
Product
EOS, Digital radiography system used in general radiographic examinations.
Manufacturer(s)
Eos Imaging Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →