PlainRecalls
FDA Devices Moderate Class II 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 rec

Reported: August 14, 2019 Initiated: July 10, 2019 #Z-2196-2019

Product 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 for Recall

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

Details

Units Affected
2
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
Location
Malvern, PA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 2.
Why was this product recalled? ▼
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2196-2019.

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