Radixact Treatment Delivery SystemRecalls & reported problems across all models
Accuray Incorporated · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 1
We found 2 models of Radixact Treatment Delivery System by Accuray Incorporated in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2022 and Aug 15, 2025 — classified as 5 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (4 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Radixact Treatment Delivery System recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 3, 2023Completed
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 Radixact Treatment Delivery System problems
Device problems
- Computer Software Problem4
- Unintended System Motion4
- Adverse Event Without Identified Device or Use Problem2
- Use of Device Problem2
- 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
- Radiation Burn1
Radixact Treatment Delivery System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Radixact™ Treatment Delivery System 1060000Accelerator, Linear, Medical1 recall10 reports
- Radixact® Treatment Delivery System 1060000Accelerator, Linear, Medical1 report
Recent Radixact Treatment Delivery System adverse event reports
The 11 most recent reports across all models, 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 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REPORTED EXPERIENCING BLISTERING AND BURNING SENSATION AFTER RECEIVING RADIATION TREATMENT ON THE RADIXACT SYSTEM.
Patient problems: Radiation Burn
MAUDE report 18355713 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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