Z-0265-2020 Class II Terminated
FDA device recall Z-0265-2020 was initiated by Siemens Medical Solutions USA, Inc on September 24, 2019 and is designated Class II. 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 interv… The recall status is terminated (terminated July 8, 2024). Affected quantity: 14 US.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- September 24, 2019
- Termination Date
- July 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 US
Product Description
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 Pattern
US in the states of: GA, IN, MO, MS, NJ, OH, PA
Code Information
software syngo CT VA20A_SP2 and active Guide&GO license