Siemens Medical Solutions USA, Inc recalls SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system

Recall date

July 13, 2016

Source

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

Recall number

Z-2625-2016

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Distributed to: MI, NY, CA, KY, ND, NE

Why it was recalled

Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired examination result is not achieved. This error only affects the automatic mode or coupled mode and does not affect the manual control of the injector.

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 Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system