CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

Lantis 3 Commander recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Lantis 3 Commander, distributed in 10 states. The recall was initiated on 10 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number 93-1296 93-1314 ***added 8/14/19*** 93-1531

Quantity recalled2

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-2196-2019
FDA event ID: 83462
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 10 Jul 2019
FDA classified: 6 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Jul 2019	Recall initiated by company
6 Aug 2019	Classified by FDA	+27 days
14 Aug 2019	Published in enforcement report	+8 days

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

Reason for recall

Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability

Product as listed by the FDA

Lantis 8.3 Commander, Model # 8148178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, Lantis Treatstation supports intensity modulation, a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

Where it was distributed

State WV NY PA FL OK FL NJ NY IL WY NY GA NY PA PA AL NJ NY ***updated 8/14/19*** OH NC

Alabama Florida Georgia Illinois North Carolina New Jersey New York Pennsylvania West Virginia Wyoming

Stores named: Target

Questions about this recall

Is Lantis 3 Commander recalled?

Yes. Siemens Medical Solutions USA recalled Lantis 3 Commander on 10 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2196-2019.

Why was it recalled?

Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability

Which lots are affected?

Serial Number 93-1296 93-1314 ***added 8/14/19*** 93-1531

Where was it sold?

State WV NY PA FL OK FL NJ NY IL WY NY GA NY PA PA AL NJ NY ***updated 8/14/19*** OH NC

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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