Z-0995-2022Class II

syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers...

Name: Z-0995-2022 syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers...
Creator: Siemens Medical Solutions USA, Inc
Published: 2022-03-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-03-07 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT... on 2022-03-07. FDA classified it as Class II and gives the reason as "Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step". 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-0995-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-07
Posted: 2022-04-22
Terminated: 2023-12-19
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.
Root cause tag: software
FDA root cause: Software change control
Action: 4/4/22 update: Urgent Medical Device Correction letter has not been issued. The proposed letter informs customers of software issue and workaround to resolve issue. It also requires electronic signature to acknowledge receipt of the notification. If you have additional questions contact the service organization at 1-800-888-7436.
Quantity in commerce: 1 (US)
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom.
Product codes and lots: Partial UDI: 04056869051314, Serial Number 112261

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0995-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0994-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-22
Z-0995-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-22
Z-0996-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-22
Z-0997-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-04	2022-04-22

Product code JAK

K211373Class IISOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO SoftwareSiemens Medical Solutions USA, Inc. / cleared 2021-08-27

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)