Radixact™ Treatment Delivery System 1060000Recalls & reported problems
Accuray Incorporated · Radixact Treatment Delivery System · Class 2
All models of Radixact Treatment Delivery System (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00811376030009), received between Jun 7, 2022 and Aug 15, 2025 — classified as 4 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (4 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Aug 3, 2023Class IICompleted
It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.
Z-2489-2023 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Computer Software Problem4
- Unintended System Motion4
- Use of Device Problem2
- Adverse Event Without Identified Device or Use Problem1
- Circuit Failure1
- Fracture1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information3
- Bone Fracture(s)1
- Limb Fracture1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2025Fracture; Fracture
BEAM STOP CRADLE HAS VISIBLE CRACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22819803 ↗InjuryMar 25, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
THERE WAS AN ALLEGATION THAT A PATIENT'S SCAN POSITION WAS DIFFERENT FROM THEIR TREATMENT POSITION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18975247 ↗InjuryFeb 9, 2024Use of Device Problem; Use of Device Problem
THE PATIENT WAS INADVERTENTLY EXPOSED TO THE TREATMENT FRACTION FOR 5.2 SECONDS WHEN IMAGING WAS INTENDED.
Patient problems: Insufficient Information
MAUDE report 18677907 ↗InjuryDec 15, 2023Use of Device Problem; Use of Device Problem
THE PATIENT WAS INADVERTENTLY EXPOSED TO THE TREATMENT FRACTION FOR 5.2 SECONDS WHEN IMAGING WAS INTENDED.
Patient problems: Insufficient Information
MAUDE report 18336039 ↗MalfunctionJun 29, 2023Computer Software Problem; Unintended System Motion; Computer Software Problem; Unintended System Motion
THE TREATMENT DELIVERY CONSOLE (TDC) FROZE AT THE END OF KVCT AND THE GANTRY PANELS SHOWED "RADIATING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17226678 ↗MalfunctionJun 8, 2023Circuit Failure; Circuit Failure
THE STATUS CONSOLE IS NOT STOPPING THE RADIATION FOLLOWING THE RX 3.0.2.1 UPDATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17086990 ↗MalfunctionJun 6, 2023Computer Software Problem; Unintended System Motion; Computer Software Problem; Unintended System Motion
THE TDC (TREATMENT DELIVERY CONSOLE) FROZE AT THE END OF KVCT AND THE GANTRY PANELS SHOWED "RADIATING".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17074756 ↗MalfunctionMay 30, 2023Computer Software Problem; Unintended System Motion; Computer Software Problem; Unintended System Motion
CUSTOMER ALLEGED THAT THE COUCH PROCEEDED WITH 99% DISPLAY ON TDC (TREATMENT DELIVERY CONSOLE) DURING KVCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17021099 ↗MalfunctionApr 18, 2023Computer Software Problem; Unintended System Motion; Computer Software Problem; Unintended System Motion
GANTRY PANELS SHOW "RADIATING" WITH PATIENT IN THE GANTRY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16765518 ↗InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem
A FIELD SERVICE ENGINEER IN JAPAN SUFFERED A BROKEN FINGER WHEN USING THE GANTRY-MOUNTED CRANE/HOIST. THE FIELD SERVICE ENGINEER TRIED TO LIFT THE JIB CRANE AND HIS HAND GOT CAUGHT BETWEEN THE GANTRY AND THE JIB, CAUSING THE INJURY.
Patient problems: Bone Fracture(s); Limb Fracture
MAUDE report 14626006 ↗
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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 · each recall links to the FDA recall notice
- 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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