—#175302

Product

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.

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K972275
Affected lot / code info: Serial Number 93-1296 93-1314 ***added 8/14/19*** 93-1531

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 #175302. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.