Siemens Medical Solutions USA, Inc recalls SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmis…

Recall date

February 15, 2018

Source

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

Recall number

Z-1458-2018

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

USA (nationally) Distribution.

Why it was recalled

to inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull bone, it may happen in rare cases that the calculated dose distribution is not appropriate and could lead to unnecessary radiation exposure

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

What was recalled

SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.