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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