Device product

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

Z-0265-2020

September 24, 2019

Class II

Product summary

Firm: Siemens Medical Solutions USA, Inc
Event: Event 83883
Status: Terminated
Classification: Class II
Quantity: 14 US
Official record key: device-enforcement:Z-0265-2020

Official wording

Reason: 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

Code information: software syngo CT VA20A_SP2 and active Guide&GO license

Distribution pattern: US in the states of: GA, IN, MO, MS, NJ, OH, PA

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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