Monaco (UDI 00858164002244)Recalls & reported problems

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 3

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Nov 22, 2019Open, Classified
Monaco is using the incorrect energy when optimizing and calculating dose.
Z-0670-2020 · Root cause: Software Design Change · FDA record ↗
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-2561-2019 · Root cause: Software design · FDA record ↗
Aug 23, 2019Terminated
Monaco is displaying the Anatomy and Beam shift direction incorrectly on the Monaco Scan and Setup Reference Report and is DICOM exporting incorrect (Anatomy/Beam) shift directions.
Z-2409-2019 · Root cause: Device Design · FDA record ↗

Device details

UDI-DI	`00858164002244`
Brand	Monaco
Model	Monaco
Company	Elekta, Inc.
Product code	MUJ · System, Planning, Radiation Therapy Treatment
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Mar 24, 2025

Device type (GMDN): Radiation therapy software

An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.