CLASS II Device recall · Reported 26 Nov 2014 · FDA Enforcement Report

Siemens SimView NT and SimView NT recalled

Siemens Medical Solutions USA is recalling Siemens SimView NT and SimView NT with IDI simulation system components, distributed nationwide in the US. The recall was initiated on 10 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel numbers: 5496992, 5497016 with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001

Quantity recalled6

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-0235-2015
FDA event ID: 69601
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 10 Oct 2014
FDA classified: 19 Nov 2014
Reported: 26 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Oct 2014	Recall initiated by company
19 Nov 2014	Classified by FDA	+40 days
26 Nov 2014	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

Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand control commands or by use of the collision detection functionality. It is possible that simulation system components could collide with patient and/or system equipment.

Product as listed by the FDA

Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of PA, KY, LA, MA, MI, and CA; and countries of: Argentina, Belarus, Bulgaria, Costa Rico, P.R. China, Curacao, Egypt, Repulic Korea, Germany, Greece, Hungary, Italy, Iraq, Jordan, Malaysia, Palestanian Ter, Poland, Thailand, Turkey, and Vietnam.

Nationwide California Kentucky Louisiana Massachusetts Michigan Pennsylvania

Questions about this recall

Is Siemens SimView NT and SimView NT with IDI simulation system components recalled?

Yes. Siemens Medical Solutions USA recalled Siemens SimView NT and SimView NT with IDI simulation system components on 10 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0235-2015.

Why was it recalled?

Which lots are affected?

Model numbers: 5496992, 5497016 with Serial numbers: 6035, 6080, 6029, 6032, 6019, 6001

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 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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