CLASS II Device recall · Reported 4 May 2022 · FDA Enforcement Report

syngo.via RT Image Suite upgraded to VB60 running recalled

Siemens Medical Solutions USA is recalling syngo.via RT Image Suite upgraded to VB60 running on Somatom go.Open Pro, distributed nationwide in the US. The recall was initiated on 7 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPartial UDI: 04056869249247, Serial Numbers 130088, 130081, 130075, 130090, 130087, 130074, 130069, 130091, 130092, 130086, 130079, 130089, 130077, 130071

Quantity recalled14 (US)

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-0997-2022
FDA event ID: 89915
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 7 Mar 2022
FDA classified: 22 Apr 2022
Reported: 4 May 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

7 Mar 2022	Recall initiated by company
22 Apr 2022	Classified by FDA	+46 days
4 May 2022	Published in enforcement report	+12 days

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

Reason for recall

Upgraded software version makes an automatic change in laser configuration settings for "markerless workflow" which may lead to the wrong laser offset coordinates being displayed in the Patient Marking step.

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 RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.

Where it was distributed

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, IL, IN, KY, MD, MO, ND, NH, NY, OH, OR, PA, SD, TX, VA and the countries of Argentina, Austria, Bahrain, Belgium, Brazil, Czechia, Denmark, France, Germany, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Switzerland, United Kingdom.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Illinois Indiana Kentucky Maryland Missouri North Dakota New Hampshire New York Ohio Oregon Pennsylvania South Dakota Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Partial UDI: 04056869249247, Serial Numbers 130088, 130081, 130075, 130090, 130087, 130074, 130069, 130091, 130092, 130086, 130079, 130089, 130077, 130071

Where was it sold?

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.

Other products in this recall event

3 other products · FDA event 89915

This product is part of a recall event; the main page for the event is syngo.via RT Image Suite upgraded to VB60 running on Somatom go.Up recalled.

Reported	Class	Recall	Company	Reason	Where
4 May 2022	CLASS II	syngo.via RT Image Suite upgraded to VB60 running on Somatom go.Up recalled	Siemens Medical Solutions USA	Device Malfunction	Nationwide
4 May 2022	CLASS II	syngo.via RT Image Suite upgraded to VB60 running on syngo.via recalled	Siemens Medical Solutions USA	Device Malfunction	Nationwide
4 May 2022	CLASS II	syngo.via RT Image Suite upgraded to VB60 running on Somatom go.Sim recalled	Siemens Medical Solutions USA	Device Malfunction	Nationwide

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