Lantis system — Class II medical device recall Z-2198-2019
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2019-08-14, distributed in AL, FL, GA, IL, NC, NJ, NY, OH…. Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
| Recall number | Z-2198-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2019-07-10 |
| Classified | 2019-08-06 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-06-03 |
| Distributed | AL, FL, GA, IL, NC, NJ, NY, OH, OK, PA, WV, WY |
| Model numbers | 5835991 |
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.
Reason for recall
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2198-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.