Z-1778-2018Class II

Syngo.Via VB20A model 1049610

Name: Z-1778-2018 Syngo.Via VB20A model 1049610
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-03-27
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-03-27 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.Via VB20A model 1049610 on 2018-03-27. FDA classified it as Class II and gives the reason as "Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to 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-1778-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-27
Posted: 2018-05-09
Terminated: 2020-06-15
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.Via VB20A model 1049610
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still use original values.
Root cause tag: software
FDA root cause: Software design
Action: On 03/27/18 Firm became aware that recall was necessary Firm initiated recall on 03/27/18 via customer information letter SY007/18/P advising that corrected values modified in the report are not save. Software patch VB20A_HF05 is being released to resolve the matter
Distribution: Nationwide
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1778-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1778-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-09

Product code LLZ

K123375Class IISyngo.viaSiemens AG / cleared 2012-11-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)