CyberKnife VSI® System 033000-000Recalls & reported problems
Accuray Incorporated · The CyberKnife VSI System is a computer controlled medical systems for planning and performing minimally invasive stereotactic radiosurgery and precision radiotherapy using a treatment radiation generator, linear accelerator, manipulator (robot), and a target locating subsystem to accurately deliver radiation to the treatment target. The target locating system provides X-rays of the treatment area taken by a diagnostic X-ray system that lets the user know the position of the target. The CyberKnife VSI Systems use skull tracking, fiducial tracking, Xsight® Spine Tracking, Xsight® Lung Tracking, and Synchrony® Respiratory Tracking for dynamic positioning and pointing of the linear accelerator. The system uses a 6 MV linear accelerator to provide a dose rate up to 1000 MU/minute. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M6580330000), received between Feb 3, 2021 and Jul 21, 2022 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Unstable1
Patient problems
- Fall1
- Incontinence1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT CONTACTED ACCURAY AND PROVIDED THE FOLLOWING INFORMATION: HAD CYBERKNIFE TREATMENT IN 2014 AT (B)(6) HOSPITAL. SHORTLY AFTER THE TREATMENT THE I HAD URINARY INCONTINENCE FOLLOWED BY LATER FECAL INCONTINENCE. BOTH ARE UNCONTROLLABLE. THERE ARE SURGERIES TO HELP CORRECT THIS PROBLEM HOWEVER I DO NOT WISH TO GO THIS ROUTE AND VERY DISSATISFIED WITH THE OUTCOME.
Patient problems: Incontinence
MAUDE report 15078585 ↗MalfunctionFeb 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SYNCHRONY CAMERA ELBOW JOINT DETACHED. THE SYNCHRONY CAMERA BOOM ARM HAD BROKEN AT THE EXTENSION POLE CONNECTION. NO DEATH OR SERIOUS INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11369713 ↗MalfunctionFeb 3, 2021Unstable; Unstable
THE PATIENT WAS SITTING UP ON THE TREATMENT COUCH AFTER TREATMENT WHILE THE STAFF MEMBER WAS AT THE PATIENT'S SIDE. WHEN THE PATIENT STOOD UP, THE COUCH TILTED AND THE PATIENT FELL OFF THE COUCH.
Patient problems: Fall
MAUDE report 11277039 ↗
Other Accelerator, Linear, Medical devices
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- 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 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.
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