Siemens Medical Solutions USA, Inc recalls syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Mode…

Recall date

July 25, 2019

Source

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

Recall number

Z-2440-2019

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide Foreign:

Why it was recalled

SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in diagnosis and/or patient rescans

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

What was recalled

syngo.CT software version VA48A_SP5.5 in the following SOMATOM computed tomography models: SOMATOM Definition Edge-Model #10590000; SOMATOM Definition AS Model #8098027; SOMATOM Definition Flash Model #10430603