Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 8/14/2019
Class II
PRODUCT
Lantis 6.1 Commander, Model # 5493072 – 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 Number: Z-2195-2019
Recall Number: Z-2196-2019
Recall Number: Z-2197-2019
Recall Number: Z-2198-2019
REASON
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc on 7/10/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2
DISTRIBUTION
US Nationwide