Trilogy 9.1Recalls & reported problems
Varian Medical Systems, Inc. · Class 2
- 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 00899475002066), received between Jun 25, 2024 and Jun 25, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K131807, K162476); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Abrasion1
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2024Use of Device Problem; Use of Device Problem
PATIENT WAS TREATED ON THE (B)(6) MACHINE, SUFFERED AN ACCIDENT ON (B)(6) 2024 AT AROUND 10:30 IN THE MORNING. IT WAS HIS FIRST SESSION AND WHEN TRYING TO TAKE AN IMAGE FOR POSITIONING, THE TECHNICIANS WERE UNABLE TO DO SO DUE TO THE LASERGUARD BEING ACTIVATED. THERAPIST DISABLED THE LASERGUARD AND TOOK THE IMAGE. WHEN STARTING THE TREATMENT ITSELF, IN THE ARC WHERE THE ACCIDENT OCCURRED, THE TABLE WAS AT A 20-DEGREE ANGLE AND THE TECHNICIANS FORGOT TO TURN THE LASERGUARD BACK ON. THE COLLIMATOR COLLIDED WITH THE PATIENT'S ELBOW, CAUSING AN INJURY (CUT) AND A DISLOCATION IN THE SHOULDER. TESTS WERE CARRIED OUT ON THE LASERGUARD WITH THE MEDICAL PHYSICS TEAM AND AT NO TIME DID IT FAIL TO DETECT AND ALSO AT NO TIME DID IT FAIL TO INFORM ON THE CONSOLE DISPLAY WHEN IT WAS DEACTIVATED (TEST PERFORMED 10 TIMES). THE LASERGUARD CALIBRATION WAS CHECKED AND ALL PARAMETERS WERE AS SPECIFIED SO THAT IT WAS PERFECTLY ALIGNED. ISSUE ATTRIBUTED TO USER ERROR, WHEN USER DID NOT TURN ON LASERGUARD BEFORE ROTATING GANTRY AFTER IMAGING.
Patient problems: Abrasion; Joint Dislocation
MAUDE report 19607774 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131807, K162476. One submission often covers many models, so check the product and lot details in each record.
- Z-0552-2014 · Nov 18, 2013 · TerminatedPlan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian
- Z-0439-2014 · Oct 24, 2013 · TerminatedC-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US
Other Accelerator, linear, medical devices
- LANDAUER microSTAR® ii Dosimetry SystemLandauer, Inc. · Accelerator, Linear, Medical38 recalls0 reports
- MOSAIQElekta, Inc. · Accelerator, Linear, Medical3 recalls112 reports
- Elekta Medical Linear Accelerator 1552093Elekta Solutions AB · Accelerator, linear, medical5 recalls6 reports
- Elekta Medical Linear Accelerator 1552092Elekta Solutions AB · Accelerator, linear, medical5 recalls0 reports
- MOSAIQ 3.2Elekta Solutions AB · Accelerator, Linear, Medical4 recalls25 reports
- Elekta Medical Linear Accelerator 1550358Elekta Solutions AB · Accelerator, linear, medical4 recalls2 reports
- Elekta Medical Linear Accelerator 1552091Elekta Solutions AB · Accelerator, linear, medical4 recalls1 report
- Elekta Medical Linear Accelerator 1550359Elekta Solutions AB · Accelerator, linear, medical4 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.