Z-1261-2018Class II

Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical...

Name: Z-1261-2018 Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical...
Creator: Siemens Medical Solutions USA, Inc
Published: 2018-01-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2018-01-10 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or... on 2018-01-10. FDA classified it as Class II and gives the reason as "When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by 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-1261-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-10
Posted: 2018-03-28
Terminated: 2018-10-02
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: When the archiving configuration is changed, data received/created after the upgrade may be flagged as "Not to be archived". This is caused by the automatic function for cleaning up temporary data being disabled by the software upgrade. Due to the disabled cleanup function, disc capacity for free space decreases faster than usual. Unless the archiving configuration and the cleanup automatic function are reverted back to the original state (prior to the software upgrade), data that was incorrectly flagged "Not to be archived" must be manually prevented from being deleted by either clinical administrator or service engineer.
Root cause tag: software
FDA root cause: Software Manufacturing/Software Deployment
Action: Customers received letters with information related to the issue and regarding the upgrade to the software version VB20A_HF04. The software was released December 22, 2017 and is available for install.
Quantity in commerce: 165 units
Distribution: Medical device software which needs to be installed.
Product codes and lots: All Syngo.via systems with VB20A. Model number 10496180.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1261-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1261-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-04	2018-03-28

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)