Z-0265-2020Class II

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

Name: Z-0265-2020 SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-09-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-09-24 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system on 2019-09-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0265-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-24
Posted: 2019-11-21
Terminated: 2024-07-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: SOMATOM go.Top, Models 11061640 & 11061648- a Computer tomography x-ray system
Product code: JAK System, X-Ray, Tomography, Computed
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
Root cause tag: software
FDA root cause: Software design
Action: Siemens issued a Customer Safety Advisory Notice to customers via CT072/19 on 9/24/2019. The letter identifies the problem, health risk and action to take: To avoid this issue, please refrain from using the i-Sequence scan mode in combination with the 3x3 mm collimation until this issue has been solved. Please use the i-Sequence with the 3x5 mm collimation instead, as here the correct dose information will be shown. This issue will be resolved with an improved software version syngo CT VA20A_SP2b. The software update will be released, free of charge, with the update CT073/19/S for all affected systems. The software update release is planned for Q3/2019. All future service packs will contain the update as well. Questions: contact service organization at 1-800-888-7436.
Quantity in commerce: 14 US
Distribution: US in the states of: GA, IN, MO, MS, NJ, OH, PA
Product codes and lots: software syngo CT VA20A_SP2 and active Guide&GO license

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0265-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0265-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21

Product code JAK

K173632Class IISOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc. / cleared 2018-04-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)