FDA Recall Terminated

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.

Recall: Z-2196-2019 · Initiated July 10, 2019

Recall

Recall Number
Z-2196-2019
Event Number
83462
Firm
Siemens Medical Solutions USA, Inc
FEI Number
2240869
Product Code
IYE
Status
Terminated
Root Cause
Other
Initiated
July 10, 2019
Posted
August 6, 2019
Terminated
June 3, 2020
Address
40 Liberty Blvd, Malvern, PA, 19355-1418

Description

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.

Reason

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

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

Quantity

2