FDA recall Z-0265-2020

Siemens Medical Solutions USA, Inc · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2019-09-24
Report date: 2019-11-27
Termination date: 2024-07-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0265-2020