—#175466

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226
Affected lot / code info: All serial numbers

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2019-07-10
Posted by FDA: 2019-08-06
Terminated: 2020-06-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175466. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.