MonacoRecalls & reported problems across all models
Elekta, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
7 open recalls name at least one Monaco model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 8
We found 5 models of Monaco by Elekta, Inc. in the FDA's device registry (GUDID). Together they are named in 45 adverse event reports in the FDA's MAUDE database, received between Dec 8, 2016 and Oct 9, 2024 — classified as 1 injury, 44 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (45 reports).
8 FDA recall records name at least one of these models by its device identifier, 7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Monaco recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · Recall details · FDA record ↗
- Sep 14, 2021Open, Classified
Contour changes can be saved on an unintended image set. In addition, these contour edits do not cause the dose to be frozen on the plans associated with that image set.
Z-2563-2021 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
- Jul 26, 2021Open, Classified
If a couch is removed while a plan is loaded, and then added back to the Studyset when the plan is unloaded, it is possible to calculate dose with the couch unassigned to the beams.
Z-2406-2021 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Apr 16, 2020Open, Classified
The Monaco RTP Radiation Treatment Planning System may change the shape and volume of the contour potentially resulting in the device delivering an inaccurate dose.
Z-1825-2020 · Root cause: Software design · Recall details · FDA record ↗
- Nov 22, 2019Open, Classified
Monaco is using the incorrect energy when optimizing and calculating dose.
Z-0670-2020 · Root cause: Software Design Change · names 3 of these models · Recall details · FDA record ↗
- Sep 4, 2019Open, Classified
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Z-2561-2019 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗
- Sep 4, 2019Open, Classified
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
Z-2560-2019 · Root cause: Software design · Recall details · FDA record ↗
- Aug 23, 2019Terminated
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
Z-2409-2019 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported Monaco problems
Device problems
- Computer Software Problem45
- Misassembled During Installation1
Patient problems
- No Consequences Or Impact To Patient16
- No Clinical Signs, Symptoms or Conditions12
- No Patient Involvement10
- No Information7
- Insufficient Information6
- Radiation Overdose4
- Radiation Underdose1
Monaco models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MonacoSystem, Planning, Radiation Therapy Treatment5 recalls9 reports
- MonacoSystem, Planning, Radiation Therapy Treatment5 recalls5 reports
- MonacoSystem, Planning, Radiation Therapy Treatment3 recalls0 reports
- MonacoSystem,Planning,Radiation Therapy Treatment1 recall23 reports
- MonacoSystem,Planning,Radiation Therapy Treatment8 reports
Recent Monaco adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionDec 29, 2021Computer Software Problem; Misassembled During Installation; Computer Software Problem; Misassembled During Installation
THE CUSTOMER REPORTED THAT IT IS POSSIBLE TO OPEN PATIENTS MULTIPLE TIMES SIMULTANEOUSLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13107544 ↗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 12719417 ↗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 ↗MalfunctionAug 25, 2021Computer Software Problem; Computer Software Problem
A CUSTOMER REPORTED THAT THE MARGIN TOOL OVERWRITES THE REFERENCE STRUCTURE SET WITHOUT FREEZING DOSE. THE CUSTOMER WAS USING VERSION (B)(4) (MFR REPORT #: 1937649-2021-00003). DURING INTERNAL INVESTIGATION, ELEKTA FOUND THAT THIS THE ISSUE ALSO OCCURS IN VERSION (B)(4). WHICH IS A DIFFERENT 510K NUMBER (K190178).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12364879 ↗MalfunctionAug 25, 2021Computer Software Problem; Computer Software Problem
A CUSTOMER REPORTED THAT THE MARGIN TOOL OVERWRITES THE REFERENCE STRUCTURE SET WITHOUT FREEZING DOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12364733 ↗MalfunctionJul 28, 2021Computer Software Problem; Computer Software Problem
A CUSTOMER REPORTED THAT THE ELEKTA UNITY COUCH BECAME UNASSIGNED IN THE TREATMENT AIDS TAB FOR A REFERENCE PLAN. THE CUSTOMER WAS USING VERSION 5.40.01. (MFR REPORT #: 1937649-2021-00001). DURING INTERNAL INVESTIGATIONS IT WAS ASCERTAINED THAT THE ISSUE ALSO OCCURS IN VERSION 5.51.10, WHICH IS A DIFFERENT 510K NUMBER (K190178).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12239189 ↗MalfunctionJul 28, 2021Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THE ELEKTA UNITY COUCH BECAME UNASSIGNED IN THE TREATMENT AIDS TAB FOR A REFERENCE PLAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12239182 ↗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 ↗MalfunctionMay 21, 2020Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT A PLAN WAS MADE IN MONACO 5.51.0 WITH 33 FIELDS OF SQUARE SIZE 10X10, ALL HAVING 100 MU AND THE SAME ISOCENTER. AN INTEREST POINT WAS PLACED IN THE ISOCENTER WHERE THE INDIVIDUAL BEAM DOSE DISTRIBUTION CAN BE READ. THE SYSTEM DID NOT TAKE INTO ACCOUNT THE LAST THREE FIELDS (BEAM 31, 32 AND 33) AND DID NOT UPDATE THE DOSE VOLUME HISTOGRAM FOR THESE BEAMS. THERE WAS NO PATIENT INVOLVEMENT, IT WAS A PHANTOM PATIENT.
Patient problems: No Information; No Patient Involvement
MAUDE report 10078453 ↗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 ↗
Other Elekta, Inc. products
All Elekta, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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