Radixact® Treatment Delivery System 1060000Recalls & reported problems
Accuray Incorporated · The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues. The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. The Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. It is not intended for diagnostic use. · Class 2
All models of Radixact Treatment Delivery System (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M65810600000), received between Dec 19, 2023 and Dec 19, 2023 — classified as 1 injury.
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 Problem1
Patient problems
- Radiation Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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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
- 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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