Siemens Medical Solutions USA, Inc recalls SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer recons…

Recall date

March 22, 2016

Source

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

Recall number

Z-1350-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Distributed to: Cincinnati, OH.

Why it was recalled

Siemens became aware that the front cover on some Siemens CT system was not properly welded. It is possible for the welded-in threaded bolt to break out of the ground plate of the front cover if the cover is opened during service. This could not happen during clinical operation. Therefore, there is no potential risk for the user or patient and the CT System has no risk for a malfunction during clinical operation

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 Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.