TomoTherapy Treatment System (Tomo HD™) H-0000-0003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M6581043090), received between Dec 1, 2016 and Feb 10, 2017 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Component Falling” (5 reports).

8 other recalls cover devices cleared under the same FDA submission (K121934); 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2017Component Falling; Unintended Movement

  A COMPLAINT WAS RECENTLY RECEIVED FOR A PROBLEM INVOLVING AN UNEXPECTED TREATMENT COUCH DESCENT. THE COUCH FELL APPROXIMATELY 2.0 CM. THERE WAS NO INJURY TO THE PATIENT OR STAFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6324570 ↗
• MalfunctionFeb 10, 2017Component Falling

  A COMPLAINT WAS RECENTLY RECEIVED FOR A PROBLEM INVOLVING AN UNEXPECTED TREATMENT COUCH DESCENT. THE COUCH FELL APPROXIMATELY 27.5 CM. THERE WAS NO INJURY TO THE PATIENT OR STAFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6324568 ↗
• MalfunctionJan 13, 2017Component Falling

  A COMPLAINT WAS RECENTLY RECEIVED FOR A PROBLEM INVOLVING AN UNEXPECTED TREATMENT COUCH DESCENT. THE COUCH FELL APPROXIMATELY 40 MM (~1.57 INCHES). THERE WAS NO INJURY TO THE PATIENT OR STAFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6251750 ↗
• MalfunctionJan 9, 2017Component Falling

  A COMPLAINT WAS RECENTLY RECEIVED FOR A PROBLEM INVOLVING AN UNEXPECTED TREATMENT COUCH DESCENT. THE COUCH FELL APPROXIMATELY 57 MM (~2.25 INCHES). THERE WAS NO INJURY TO THE PATIENT OR STAFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233853 ↗
• MalfunctionJan 9, 2017Component Falling

  A COMPLAINT WAS RECENTLY RECEIVED FOR A PROBLEM INVOLVING AN UNEXPECTED TREATMENT COUCH DESCENT. THE COUCH FELL APPROXIMATELY 180 MM (~7 INCHES). THERE WAS NO INJURY TO THE PATIENT OR STAFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6233849 ↗
• MalfunctionDec 1, 2016Device Operates Differently Than Expected

  A COMPLAINT WAS RECENTLY RECEIVED FOR A PROBLEM INVOLVING A FLEX PIVOT JOINT FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6140277 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121934. One submission often covers many models, so check the product and lot details in each record.

• Z-0784-2021 · Dec 10, 2020 · Terminated
  TomoTherapy Treatment System - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic ra
• Z-0289-2018 · Nov 17, 2017 · Terminated
  TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of ra
• Z-0287-2018 · Nov 17, 2017 · Terminated
  TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of rad
• Z-0286-2018 · Nov 17, 2017 · Terminated
  Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of
• Z-0288-2018 · Nov 17, 2017 · Terminated
  TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radi
• Z-0507-2015 · Nov 21, 2014 · Terminated
  TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
• Z-2239-2014 · Jul 17, 2014 · Terminated
  TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2). .
• Z-2240-2014 · Jul 16, 2014 · Terminated
  TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). The TomoTherapy treatment system is int