Eclipse Treatment Planning System for External Beam Radiation Therapy 16.1Recalls & reported problems
Varian Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855141006080), received between Nov 17, 2020 and Nov 17, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2020Use of Device Problem; Use of Device Problem
THE CUSTOMER REPORTED THAT ON (B)(6) 2020 A PLAN THAT WAS CALCULATED IN ECLIPSE HAD AN UNEXPECTED DOSE DISTRIBUTION WITH HIGH DOSE EXTENDING OUTSIDE THE PTV AND TOWARDS THE PATIENT SKIN. THE PATIENT HAD NOT BEEN TREATED. THE ISSUE WAS REPRODUCIBLE AT THE CUSTOMER SITE FOR THE SAME PATIENT. THE PATIENT DATA WAS RETRIEVED FROM THE CUSTOMER SITE AND TESTED WITH VARIAN STANDARD BEAM MODEL AND ALGORITHMS, AND SAME DOSE CONSTRAINTS, BUT THE ISSUE WAS NOT REPRODUCIBLE. AFTER SOME TROUBLESHOOTING BY VARIAN SERVICE/HELPDESK, IT WAS FOUND THAT THE ISSUE WAS DUE TO THE ELECTRON CALIBRATION CURVE THAT WAS INCORRECTLY DEFINED AS ABSOLUTE DENSITY, INSTEAD OF AS RELATIVE TO WATER DENSITY. NO INJURY OR DEATH WAS REPORTED.
Patient problems: No Information
MAUDE report 10852382 ↗
Other System, planning, radiation therapy treatment devices
- RayStation 9Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment12 recalls0 reports
- RayStation 9B SP1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment11 recalls0 reports
- RayStation 8.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment11 recalls0 reports
- RayStation 10.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls1 report
- RayStation 8.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls0 reports
- RayStation 10.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 10.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 8.1.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page