Siemens Medical Solutions USA product recalled over injury risk

Recall date

October 7, 2019

Source

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

Official notice title

Siemens Medical Solutions USA, Inc recalls Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), S…

Recall number

Z-0406-2020

FDA classification

Class II

Brand / firm

Siemens Medical Solutions USA, Inc

Sold / distributed

Nationwide

Why it was recalled

Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes

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

What was recalled

Software versions syngo CT VB20 running on the following Siemens SOMATOM CT Scanner. SOMATOM Force (Model #10742326), SOMATOM Definition As (Model #8098027), SOMATOM Definition Edge (Model #10590000), SOMATOM Definition Flash (Model #10430603), SOMATOM Drive (Model #10431700), SOMATOM Confidence (Model #10590100), and SOMATOM Edge Plus (Model # 10267000) with software syngo CT VB20