TomoTherapy Treatment Delivery System with iDMS 1068283Recalls & reported problems
Accuray Incorporated · The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M65810682830), received between Feb 4, 2022 and Feb 4, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loss of Data” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K171837); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Loss of Data2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 13449864 ↗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 13449861 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K171837. One submission often covers many models, so check the product and lot details in each record.
- Z-0785-2021 · Dec 10, 2020 · TerminatedTomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy,
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- Elekta Medical Linear Accelerator 1552091Elekta Solutions AB · Accelerator, linear, medical4 recalls1 report
- Elekta Medical Linear Accelerator 1550359Elekta Solutions AB · Accelerator, linear, medical4 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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