Monaco (UDI 00858164002190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00858164002190), received between Aug 16, 2019 and Aug 25, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (5 reports).

5 FDA recall records name this device's identifier, 5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · 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 · Recall details · FDA record ↗

3. 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 ↗

4. Nov 22, 2019Open, Classified

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

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

5. 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 ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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

  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 ↗
• 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 9888896 ↗
• MalfunctionOct 2, 2019Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED A DISCREPANCY BETWEEN MONACO GUI (GRAPHICAL USER INTERFACE) AND BEHAVIOR.

  Patient problems: No Patient Involvement

  MAUDE report 9144779 ↗
• MalfunctionAug 16, 2019Computer Software Problem; Computer Software Problem

  THE CUSTOMER REPORTED AN ADAPT TO SHAPE (ATS) LAYERING AND DENSITY PROBLEM. BASED UPON THE AVAILABLE INFORMATION THERE HAS BEEN NO ACTUAL MISTREATMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8900392 ↗