Z-2198-2019 Class II Terminated
FDA device recall Z-2198-2019 was initiated by Siemens Medical Solutions USA, Inc on July 10, 2019 and is designated Class II. Reason for recall: Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability The recall status is terminated (terminated June 3, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- July 10, 2019
- Termination Date
- June 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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.
Reason for Recall
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
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
Code Information
All serial numbers