Z-0808-2018Class II

Syngo.via systems with SW VB20A

Name: Z-0808-2018 Syngo.via systems with SW VB20A
Creator: Siemens Medical Solutions USA, Inc
Published: 2017-08-31
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2017-08-31 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.via systems with SW VB20A on 2017-08-31. FDA classified it as Class II and gives the reason as "A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with 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-0808-2018
Classification: Class II
Status: Terminated
Initiated: 2017-08-31
Posted: 2018-03-01
Terminated: 2018-10-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.via systems with SW VB20A
Product code: LLZ System, Image Processing, Radiological
Reason for recall: A software update was released on August 22, 2017. Performing this software installation and upgrading syngo.via system to the software version VB20A_HF02 will resolve various bugs and inconsistent diagnosis with the old system.
Root cause tag: software
FDA root cause: Software Design Change
Action: On August 25, 2017 an URGENT letter was issued to customers notify of a system update for Syngo.via systems with SW VB20A. The software was released on August 22, 2017. Several bugs and inconsistent diagnoses were detected and this software is intended to correct these. If you have any questions, call Siemens Customer Care Centre at 888-826-9702 (24/7).
Quantity in commerce: 30
Distribution: Nationwide Distribution.
Product codes and lots: 10496180

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0808-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0808-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-03-01

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)