CyberKnife® VSI™ System 032500-M-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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M6580325000), received between Jul 22, 2022 and Jul 22, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unstable” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K091999); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Unstable1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2022Unstable; Unstable
THE SYNCHRONY BOOM ARM HAD UNINTENDED MOTION. NO DEATH OR SERIOUS INJURY WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15089213 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K091999. One submission often covers many models, so check the product and lot details in each record.
- Z-1098-2012 · Jan 16, 2012 · TerminatedCyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose cal
- Z-0382-2012 · Nov 7, 2011 · TerminatedCyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife treatment is indicated for the treatment planning and image guided stereotactic radiosurger
- Z-0714-2011 · Oct 28, 2010 · TerminatedCyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment planning and image-
Other Accelerator, Linear, Medical devices
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- 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 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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