Monaco (UDI 00858164002169)Recalls & reported problems
Elekta, Inc. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Elekta Monaco radiation therapy planning system is used to plan radiation treatment. The 23 reports that name its identifier mostly describe software problems with incorrect displays of doses, treatment plans and machine settings, including 2 mentions of radiation overdose, with no deaths and 1 injury. It has 1 open recall started in February 2023 about inaccurate dose display after re-optimizing plans.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00858164002169), received between Dec 8, 2016 and Oct 9, 2024 — classified as 1 injury, 22 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (23 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Feb 28, 2023Open, Classified
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Z-1233-2023 · Root cause: Software design · FDA record ↗
Most reported problems
Device problems
- Computer Software Problem23
Patient problems
- No Consequences Or Impact To Patient10
- No Clinical Signs, Symptoms or Conditions6
- No Information6
- Insufficient Information3
- No Patient Involvement3
- Radiation Overdose2
- Radiation Underdose1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 9, 2024Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A DISPLAY ISSUE WHEN VISUALISING THE MULTI-LEAF COLLIMATOR FOR TRANSVERSE SLICES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20407226 ↗MalfunctionJan 26, 2023Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE PLAN EXPORTED FROM MONACO DIFFERS TO WHAT IS BEING DISPLAYED BY ISODOSES AND DVH.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16246476 ↗MalfunctionOct 29, 2021Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MONACO TRANSFERS A VALUE FOR THE BOLUS DESCRIPTION TO MOSAIQ EVEN IF THERE IS NO BOLUS DEFINED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12719377 ↗MalfunctionSep 9, 2020Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MONACO TBI SSE 350CM PLAN TEMPLATE SHOWS A STRANGE ISODOSE LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10507472 ↗MalfunctionJul 31, 2020Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT A VMAT PLAN GAVE THE WRONG VMAT ROTATION ARC.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Information
MAUDE report 10349038 ↗MalfunctionJul 15, 2020Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A FAILURE OF DOSE DISTRIBUTION IN QA MODE OF MONACO.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10276949 ↗MalfunctionApr 21, 2020Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED BEAMS WITH MU CALCULATED ARE SHOWING 0% WEIGHT IN THE PRESCRIPTION TAB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9981769 ↗MalfunctionApr 21, 2020Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED BEAMS WITH MU CALCULATED ARE SHOWING 0% WEIGHT IN THE PRESCRIPTION TAB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9981716 ↗MalfunctionMar 19, 2020Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT ON OPENING CERTAIN MONACO FILES ALREADY CALCULATED THEY EXPERIENCED A LOSS OF THE CALCULATION.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9853611 ↗MalfunctionFeb 19, 2020Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE STRUCTURE DISPLAY HAS FLIPPED IN MONACO IN THE TSC VIEWS.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 9726927 ↗MalfunctionDec 4, 2019Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MONACO EXCLUDES BEAM AFTER RECALCULATION. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO ACTUAL MISTREATMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9408763 ↗MalfunctionNov 26, 2019Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MONACO CALCULATED WRONGLY THE MU.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Information
MAUDE report 9374881 ↗MalfunctionJul 17, 2019Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED MU CALCULATION WRONG IN 3D PLAN. BASED ON AVAILABLE INFORMATION THERE WAS NO MISTREATMENT.
Patient problems: No Patient Involvement
MAUDE report 8797354 ↗MalfunctionJun 7, 2019Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED INCORRECT MU'S CALCULATION.
Patient problems: No Information; Radiation Overdose
MAUDE report 8678446 ↗MalfunctionJun 6, 2019Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED A MONACO DICOM EXPORT ERROR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8674726 ↗MalfunctionMay 30, 2019Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE ASYMMETRIC SEGMENTED FIELDS FROM MONACO ARE SHOWING WRONG JAW POSITIONS IN MOSAIQ.
Patient problems: No Information
MAUDE report 8653947 ↗MalfunctionAug 22, 2018Computer Software Problem; Computer Software Problem
(B)(6) IS ALLOWING THE CREATION OF MULTIPLE EXTERNAL CONTOURS RESULTING IN THE SSD (SOURCE-TO-SKIN-DISTANCE) NOT BEING CALCULATED CORRECTLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7804497 ↗MalfunctionJun 21, 2018Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE PLAN EXPORTED FROM (B)(4) DIFFERS TO WHAT IS BEING DISPLAYED BY ISODOSES AND DOSE VOLUME HISTOGRAM (DVH).
Patient problems: Radiation Underdose
MAUDE report 7624623 ↗InjuryFeb 1, 2018Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT WRONG DOSE-MU IN SEGMENTED 3D PLAN. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN AN ACTUAL MISTREATMENT WHICH HAS LED TO SERIOUS INJURY.
Patient problems: Radiation Overdose
MAUDE report 7234006 ↗MalfunctionJan 24, 2018Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MONACO WILL DISPLAY THE INCORRECT MU FOR A 3D PLAN. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO MISTREATMENT.
Patient problems: No Patient Involvement
MAUDE report 7215480 ↗MalfunctionJan 3, 2018Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE WRONG MU WAS CALCULATED FOR SEGMENT FIELDS. BASED ON THE AVAILABLE INFORMATION THERE HAVE BEEN NO ACTUAL MISTREATMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7159533 ↗MalfunctionNov 8, 2017Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MONACO WILL DISPLAY THE WRONG MU OR DOSE VALUE ON PRESCRIPTION UI FOR A 3D PLAN. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO MISTREATMENT.
Patient problems: No Patient Involvement
MAUDE report 7008658 ↗MalfunctionDec 8, 2016Computer Software Problem; Computer Software Problem
CONTOURS ARE NOT HANDLED CORRECTLY IF THE CT DATASET CONTAINS SLICES WITH DICOM Z COORDINATES OF XX.X50MM. IF THE CT DATA CONTAIN SLICES THAT OCCUR AT POSITIONS OF XX.X50MM, THERE CAN BE PORTIONS OF THE VOLUME WHERE THERE IS A MISMATCH BETWEEN THE CONTOUR GRAPHICS SHOWN ON THE SCREEN AND THE CONTOUR DATA USED DURING THE OPTIMIZATION AND CALCULATION OF DOSE. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO ACTUAL MISTREATMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6154072 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.