CyberKnife® Treatment Delivery System 0660000Recalls & reported problems
Accuray Incorporated · The CyberKnife® Treatment Delivery System (CKTDS) is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision® Treatment Planning System and iDMS™ Data Management System. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00811376030016), received between Oct 28, 2021 and Aug 21, 2025 — classified as 3 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
4 other recalls cover devices cleared under the same FDA submission (K170788); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Detachment of Device or Device Component2
- Unintended System Motion2
- Electrical /Electronic Property Problem1
- Therapy Delivered to Incorrect Body Area1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information2
- Nerve Damage1
- Neuropathy1
- Ulcer1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RECTAL TOXICITY DUE TO PROSTATE TREATMENT.
Patient problems: Insufficient Information
MAUDE report 22671925 ↗MalfunctionOct 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THE MLC (MULTI-LEAF COLLIMATOR) DROPPED OFF OF THE SYSTEM AT PERCH AFTER AN ERROR OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20470488 ↗MalfunctionJun 18, 2024Unintended System Motion; Unintended System Motion
STANDARD TREATMENT COUCH ROLL JOINT WAS LOOSE AND CIRCLIP CAME OUT CAUSING THE COUCH TO ROTATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19562294 ↗MalfunctionSep 8, 2023Unintended System Motion; Unintended System Motion
THE STANDARD TREATMENT COUCH SNAP RING DROPPED, CAUSING THE COUCH TO ROLL DURING PATIENT ALIGNMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17710153 ↗MalfunctionMar 21, 2023Unstable; Unstable
THE CYBERKNIFE IMAGING HAD SHOWN A COUCH SAG MORE THAN 10 DEGREES FOR A PROSTATE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16585590 ↗InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SIDE EFFECT - ANESTHESIA DELAROSA (AD).
Patient problems: Nerve Damage; Neuropathy
MAUDE report 15773666 ↗MalfunctionJul 22, 2022Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component; Therapy Delivered to Incorrect Body Area; Detachment of Device or Device Component
CUSTOMER HAD A FAILED AQA (AUTOMATIC QUALITY ASSURANCE). FSE (FIELD SERVICE ENGINEER) FOUND THE FCA (FIXED COLLIMATOR ASSEMBLY) HAD DROPPED INSIDE THE COVERS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15089280 ↗MalfunctionOct 28, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT IS REPORTED THAT A TRANSFORMER WITHIN THE X-RAY GENERATOR OF CYBERKNIFE TREATMENT DELIVERY SYSTEM CAUGHT FIRE DURING INSTALLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12711568 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K170788. One submission often covers many models, so check the product and lot details in each record.
- Z-2644-2026 · Jun 16, 2026 · Open, ClassifiedCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
- Z-2640-2026 · Jun 16, 2026 · Open, ClassifiedCyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator
- Z-1023-2025 · Dec 23, 2024 · CompletedCyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery Syste
- Z-1272-2021 · Feb 26, 2021 · TerminatedCyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in
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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