Monaco 6.2Recalls & reported problems
Elekta Solutions AB · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07340201500064), received between Mar 27, 2024 and Sep 24, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Application Network Problem1
- Application Program Problem: Dose Calculation Error1
- Application Program Problem: Parameter Calculation Error1
- Computer Software Problem1
- No Apparent Adverse Event1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Application Network Problem
The customer reported that the SRS Cone plan export for the counter clockwise beam is not being transferred correctly to MOSAIQ.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880207 ↗MalfunctionSep 5, 2025Application Program Problem: Parameter Calculation Error; Insufficient Device Problem Information; Application Program Problem: Parameter Calculation Error; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE ADAPT SETUP MEAN ED FOR EXTERNAL CONTOUR IS DIFFERENT FOR TWO IDENTICAL STUDY SETS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 22976758 ↗MalfunctionAug 14, 2025Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error
INTERNAL TESTING FOUND THAT WHEN CALCULATING A QA PLAN, SEGMENTS ARE SKIPPED IN THE CALCULATION BUT REMAIN IN THE PLAN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22802614 ↗MalfunctionApr 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REPORTED INCORRECT PATIENT DATA LOADED IN CONTOURING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21918076 ↗MalfunctionMar 27, 2024Computer Software Problem; No Apparent Adverse Event; Computer Software Problem; No Apparent Adverse Event
THE CUSTOMER REPORTED THAT THE CTV (CLINICAL TARGET VOLUME) VOLUME CHANGES DURING ATS (ADAPT TO SHAPE).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18985284 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.