Monaco (UDI 00858164002275)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 00858164002275), received between Oct 8, 2021 and Apr 14, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (3 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.
Most reported problems
Device problems
- Computer Software Problem3
- Incorrect Measurement1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2023Computer Software Problem; Incorrect Measurement; Computer Software Problem; Incorrect Measurement
THE CUSTOMER REPORTED THAT A SCAN REFERENCE SHIFT WAS INCORRECT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16742407 ↗MalfunctionDec 23, 2022Computer Software Problem; Non Reproducible Results; Computer Software Problem; Non Reproducible Results
THE CUSTOMER REPORTED THAT MONACO 6.00.01 SENDS THE INCORRECT NUMBER OF FRACTIONS IN DICOM RTPLAN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16041266 ↗MalfunctionOct 8, 2021Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THEY CANNOT USE NON-COPLANAR ARCS/BEAMS WITH VERSA HD AND/OR AGILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12598120 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.