Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system

Recall date
September 24, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0265-2020
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
US in the states of: GA, IN, MO, MS, NJ, OH, PA

Why it was recalled

SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No dose documentation and no Dose Alert for the special mode i- Sequence during interventional procedures

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 go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system

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