openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 4
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.
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
Code information
Serial Number 93-1158 93-0803
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
device · product 2 of 4
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.
Potentially affected by the Microsoft Windows Remote Desktop Protocol (RDP) vulnerability
Code information
Serial Number 93-1296 93-1314 ***added 8/14/19*** 93-1531
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
device · product 3 of 4
Lantis Commander, Model # 4503178 - 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.
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
device · product 4 of 4
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.
