Medical device recalls Moderate risk

Siemens Medical Solutions USA, Inc recalls Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow the radiation therapist to de…

Recall date
July 10, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2198-2019
FDA classification
Class II
Brand / firm
Siemens Medical Solutions USA, Inc
Sold / distributed
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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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