TomoHDA® Treatment Delivery System 1018286-000Recalls & reported problems
Accuray Incorporated · TomoTherapy Treatment System (H Series) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M65810182860), received between Nov 10, 2022 and Oct 12, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Fell” (1 report).
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
- Device Fell1
- Smoking1
Patient problems
- Bone Fracture(s)1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 12, 2023Device Fell; Device Fell
THE FIELD SERVICE ENGINEER'S RIGHT HAND WAS INJURED (LACERATION AND FINGER FRACTURE, BLEEDING AND SWELLING) BY THE FALLING BOOM CRANE WHEN PERFORMING SERVICE.
Patient problems: Bone Fracture(s)
MAUDE report 17922109 ↗MalfunctionNov 10, 2022Smoking; Smoking
THERE HAD BEEN SMOKE FROM UPS2 AND THE FIRE DEPARTMENT RESPONDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15773626 ↗
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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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