CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report

Syngo.via systems with SW VB20A recalled

Siemens Medical Solutions USA is recalling Syngo.via systems with SW VB20A, distributed nationwide in the US. The recall was initiated on 31 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes10496180

Quantity recalled30

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-0808-2018
FDA event ID: 79178
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 31 Aug 2017
FDA classified: 1 Mar 2018
Reported: 7 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

31 Aug 2017	Recall initiated by company
1 Mar 2018	Classified by FDA	+182 days
7 Mar 2018	Published in enforcement report	+6 days

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

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.

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 systems with SW VB20A

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

10496180

Where was it sold?

Nationwide Distribution.

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 26 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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