Z-2198-2019Class II

Lantis system (pre-2003), Model #5835991 -

Name: Z-2198-2019 Lantis system (pre-2003), Model #5835991 -
Creator: Siemens Medical Solutions USA, Inc
Published: 2019-07-10
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2019-07-10 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the... on 2019-07-10. FDA classified it as Class II and gives the reason as "Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2198-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-10
Posted: 2019-08-06
Terminated: 2020-06-03
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Lantis system (pre-2003), Model #5835991 - 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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
FDA root cause: Other
Action: We strongly recommend the following: Disable Remote Desktop Protocol (RDP) or close port 3389/tcp Ensure you have appropriate backups and system restoration procedures. If you have any questions or require assistance, please contact our service organization at 1-800-888-7436.
Distribution: 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
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2198-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2195-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2196-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2197-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06
Z-2198-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-06

Product code IYE

K060226Class IIOncor ExpressionSiemens Medical Solutions USA, Inc. / cleared 2006-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)