Monaco (UDI 00858164002152)Recalls & reported problems
Elekta, Inc. · Class 2
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00858164002152), received between Dec 22, 2016 and Mar 27, 2020 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (8 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 Problem8
Patient problems
- Insufficient Information2
- No Consequences Or Impact To Patient2
- No Patient Involvement2
- Radiation Overdose2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
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 9888942 ↗MalfunctionJan 12, 2018Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED INCORRECT MONITOR UNITS FOR MONACO 3D PLAN. BASED ON THE AVAILABLE INFORMATION THERE HAVE BEEN NO ACTUAL MISTREATMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7185203 ↗MalfunctionJan 8, 2018Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THEY HAVE TWO PATIENTS PRESENTING RADIATION DAMAGE FROM ONE AND HALF YEARS AGO. BASED UPON THE AVAILABLE INFORMATION THE PATIENT RECEIVED A DOSE OF RADIATION THAT HAS LED TO SERIOUS INJURY.
Patient problems: Radiation Overdose
MAUDE report 7171667 ↗MalfunctionJan 8, 2018Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT THEY HAVE TWO PATIENTS PRESENTING RADIATION DAMAGE FROM ONE AND HALF YEARS AGO. BASED UPON THE AVAILABLE INFORMATION THE PATIENT RECEIVED A DOSE OF RADIATION THAT HAS LED TO SERIOUS INJURY.
Patient problems: Radiation Overdose
MAUDE report 7171513 ↗MalfunctionNov 22, 2017Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT MONACO WILL DISPLAY THE INCORRECT MU FOR A 3D PLAN. BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO MISTREATMENT.
Patient problems: No Patient Involvement
MAUDE report 7052006 ↗MalfunctionOct 11, 2017Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED AN ERROR TO THE DOSE CALCULATION OF A PATIENT TREATED IN (B)(6) 2016. THE ERROR WAS DISCOVERED BY THE SITE DURING ROUTINE QA PROCEDURES.
Patient problems: Insufficient Information
MAUDE report 6939523 ↗MalfunctionOct 11, 2017Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT A PATIENT WAS MISTREATED WITH VERSION (B)(4) BEFORE THE UPGRADE TO 5.10.04. IN (B)(6).
Patient problems: Insufficient Information
MAUDE report 6939520 ↗MalfunctionDec 22, 2016Computer Software Problem; Computer Software Problem
THE CUSTOMER REPORTED THAT A PATIENT HAS RECEIVED THE FIRST FRACTION OF THE TREATMENT BEFORE REALISING THAT THE WRONG DOSE WAS CALCULATED IN (B)(6). BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN AN ACTUAL MISTREATMENT, HOWEVER THE SEVERITY DID NOT LEAD TO SERIOUS CLINICAL OUTCOME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6198322 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.