CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report

Syngo.via recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Syngo.via. The recall was initiated on 10 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Syngo.via systems with VB20A. Model number 10496180.

Quantity recalled165 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1261-2018
FDA event ID: 79513
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 10 Jan 2018
FDA classified: 28 Mar 2018
Reported: 4 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

10 Jan 2018	Recall initiated by company
28 Mar 2018	Classified by FDA	+77 days
4 Apr 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Medical device software which needs to be installed.

Questions about this recall

Is Syngo.via recalled?

Yes. Siemens Medical Solutions USA recalled Syngo.via on 10 Jan 2018. The recall is Class II and its status is Terminated. Recall number Z-1261-2018.

Why was it recalled?

Which lots are affected?

All Syngo.via systems with VB20A. Model number 10496180.

Where was it sold?

Medical device software which needs to be installed.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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