Data Foundry

Medical device recalls 2019

SOMATOM go — Class II medical device recall Z-0265-2020

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-11-27, distributed in GA, IN, MO, MS, NJ, OH, PA. SOMATOM go.Top (Models #11061640 & 11061648) with software syngo CT VA20A_SP2 and active Guide&GO license No d

Recall numberZ-0265-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated2019-09-24
Classified2019-11-21
Reported by FDA2019-11-27
Terminated2024-07-08
DistributedGA, IN, MO, MS, NJ, OH, PA
Quantity14 us
Reason classessoftware
Model numbers11061640, 11061648

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0265-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.