Monaco (UDI 00858164002268)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00858164002268), received between Aug 1, 2019 and Dec 29, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (9 reports).

5 FDA recall records name this device's identifier, 4 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.

Recalls naming this device

1. 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 · FDA record ↗

2. 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 · FDA record ↗

3. Nov 22, 2019Open, Classified

   Monaco is using the incorrect energy when optimizing and calculating dose.

   Z-0670-2020 · Root cause: Software Design Change · FDA record ↗

4. 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 · FDA record ↗

5. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 27, 2020Computer Software Problem; Computer Software Problem

  DURING AN INTERNAL INVESTIGATION, WHEN EDITING A CONTOUR AND CLICKING ON A CORONAL OR SAGITTAL SLICE, THE 3D VOLUME IS RECREATED UNNECESSARILY WHICH COULD RESULT IN A VOLUME CHANGE.

  Patient problems: No Patient Involvement

  MAUDE report 9888950 ↗
• MalfunctionAug 16, 2019Computer Software Problem; Computer Software Problem

  DURING ELEKTA INTERNAL INVESTIGATIONS AN ADAPT ANATOMY LAYERING AND DENSITY PROBLEM WAS FOUND.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8900401 ↗
• MalfunctionAug 1, 2019Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT MONACO 5.51 PILOT: ANATOMY VS BEAM OFFSET REFERENCES. THERE HAS BEEN NO ACTUAL MISTREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849981 ↗
• MalfunctionAug 1, 2019Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED THAT MONACO 5.51 PILOT: DIRECTION SHIFTS FROM THE DICOM RT PLAN EXPORT ARE IN OPPOSITE DIRECTIONS OF HOW THEY SHOULD BE ENTERED INTO MOSAIQ. THERE HAS BEEN NO ACTUAL MISTREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849925 ↗