CLASS II Device recall · Reported 16 May 2018 · FDA Enforcement Report

Syngo.Via VB20A recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Syngo.Via VB20A, distributed nationwide in the US. The recall was initiated on 27 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll

Quantity recalledN/A

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-1778-2018
FDA event ID: 79888
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 27 Mar 2018
FDA classified: 9 May 2018
Reported: 16 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

27 Mar 2018	Recall initiated by company
9 May 2018	Classified by FDA	+43 days
16 May 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

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.

Product as listed by the FDA

Syngo.Via VB20A model 1049610

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All

Where was it sold?

Nationwide

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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