Clinac iX 9.1Recalls & reported problems
Varian Medical Systems, Inc. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00899475002042), received between Aug 23, 2023 and Sep 26, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K131807, K133331, K162476, K203766); 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.
Most reported problems
Device problems
- Device Handling Problem1
- Inadequate User Interface1
- Unintended Movement1
Patient problems
- Bone Fracture(s)1
- Laceration(s)1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 26, 2023Inadequate User Interface; Unintended Movement; Inadequate User Interface; Unintended Movement
InjuryAug 23, 2023Device Handling Problem; Device Handling Problem
INFORMATION PROVIDED BY(B)(6) 2023 (AWARE DATE): EVENT DATE:(B)(6) 2023. - SEQUENCE OF EVENTS LEADING TO THE INJURY. THE COUCH WAS ANGLED AND THE THERAPIST DIDN'T PERCEIVE AND ROTATED THE GANTRY - INFORMATION ABOUT THE PATIENT'S TREATMENT. ID1:(B)(6) / ID2: (B)(6). - PLAN INFORMATION LOGS PROVIDED. - INJURY DETAILS PATIENT HAD A NOSE INJURY, CRUSHED NOSE LEADING TO A LIGHT FRACTURE. - WAS ANY MEDICAL INTERVENTION NECESSARY AFTER THE INCIDENT? INFORMATION PROVIDED BY ON (B)(6) 2023: HE REPORTS SHE DID NOT NEED ANY SURGICAL PROCEDURES, DRESSING OR SUTURING. EMPHASIZED THAT THE PATIENT IS VERY WELL. THE CUSTOMER MENTIONED THE PROBLEM WAS HUMAN ERROR AND THE MACHINE HAVE NO ERRORS.
Patient problems: Bone Fracture(s)
MAUDE report 17607352 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131807, K133331, K162476, K203766. One submission often covers many models, so check the product and lot details in each record.
- Z-2654-2014 · Aug 18, 2014 · Terminated4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear accelerator parameters and preventing
- 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.