Eos Imaging Inc recalls EOS, Digital radiography system used in general radiographic examinations.

Recall date

February 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1460-2015

FDA classification

Class II

Brand / firm

Eos Imaging Inc

Sold / distributed

US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

EOS, Digital radiography system used in general radiographic examinations.