Z-2688-2020Class II

syngo.via RT Image Suite with software versions syngo.via VB30 or VB40

Name: Z-2688-2020 syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Creator: Siemens Medical Solutions USA, Inc
Published: 2020-06-24
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2020-06-24 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 on 2020-06-24. FDA classified it as Class II and gives the reason as "If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the...". 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-2688-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-24
Posted: 2020-07-22
Terminated: 2023-04-05
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurence of this issue is very unlikely and has never been reported so far.
Root cause tag: software
FDA root cause: Software design
Action: Siemens Healthcare Diagnostics sent a letter notification to customers dated June 23, 2020. The described issue will be solved with a service pack for software versions syngo.via VB30 and syngo.via VB40. Depending on your current software version, the service pack VB30A_HF08 will be installed with update SY039/20/S or the service pack VB40B_HF01 with update SY040/20/S as soon as it is available.
Quantity in commerce: 21 units
Distribution: US Nationwide distribution including in the states of AZ, MA, WI, FL, PA. TX, MD, LA, TX, MN, MI, NY, SC, OH, GA, CA, IL, MO, CA, TX.
Product codes and lots: syngo.via VB30 or VB40: All Lots Model #: 10496180

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2688-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2688-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-22

Product code MUJ

K192065Class IISyngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc. / cleared 2019-09-18

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)