Monaco (UDI 07340201500033)Recalls & reported problems
Elekta Solutions AB · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07340201500033), received between Sep 7, 2023 and Jun 13, 2025 — classified as 3 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 Program Problem: Dose Calculation Error1
- Computer Software Problem1
- Loss of Data1
- No Apparent Adverse Event1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2025Application Program Problem: Dose Calculation Error; Insufficient Device Problem Information; Application Program Problem: Dose Calculation Error; Insufficient Device Problem Information
THE CUSTOMER REPORTED A DOSE DISCREPANCY BETWEEN INITIAL AND SECONDARY CALCULATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22200947 ↗MalfunctionApr 4, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
THE CUSTOMER REPORTED THAT THE WRONG DOSE IS ASSOCIATED WITH (B)(6).
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21771682 ↗MalfunctionSep 7, 2023Computer Software Problem; Loss of Data; Computer Software Problem; Loss of Data
THE CUSTOMER REPORTED THAT BRAIN -PTV (PLANNED TARGET VOLUME/PLANNING TUMOUR VOLUME) IS READ BY MONACO AS BRAIN +PTV AND THERE IS NO ALERT FROM MONACO.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17697809 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.