Accuray Precision® Treatment Planning System 1049210-000Recalls & reported problems
Accuray Incorporated · Accuray Precision® Treatment Planning System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00811376030221), received between Jan 6, 2022 and Nov 25, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Loss of Data” (3 reports).
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
- Loss of Data3
- Computer Software Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025Computer Software Problem; Computer Software Problem
THE SYSTEM KEPT USING THE OLD SIMULATION STRUCTURES, AND NOT THE ONE USED IN THE PLAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23651680 ↗MalfunctionMar 9, 2022Loss of Data; Loss of Data
A FRACTION WAS DELIVERED AND COMPLETED NORMALLY WITHOUT ERRORS, BUT THE SYSTEM DID NOT MARK THE FRACTION AS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13716685 ↗MalfunctionFeb 4, 2022Loss of Data; Loss of Data
A FRACTION WAS DELIVERED AND COMPLETED NORMALLY WITHOUT ERRORS, BUT THE SYSTEM DID NOT MARK THE FRACTION AS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13449862 ↗MalfunctionJan 6, 2022Loss of Data; Loss of Data
A FRACTION WAS DELIVERED AND COMPLETED NORMALLY WITHOUT ERRORS, BUT THE SYSTEM DID NOT MARK THE FRACTION AS COMPLETED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13175552 ↗
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- RayStation 10.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls1 report
- RayStation 8.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment10 recalls0 reports
- RayStation 10.0.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 10.0Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 recalls0 reports
- RayStation 8.1.1Raysearch Laboratories AB (Publ) · System, Planning, Radiation Therapy Treatment9 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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