MAUDE Adverse Event Report: Elekta Solutions AB MONACO; System, Planning, Radiation Therapy Treatment

Lot Number	6.2.3.0
Medical Device Problem Code	Application Network Problem (2879)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the srs cone plan export for the counter clockwise beam is not being transferred correctly to mosaiq.
Additional Manufacturer Narrative
Manufacturing date is not on the label as pi, but it is known so field h4 has been completed with this information.The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

• Brand Name: MONACO
• Common Device Name: System, Planning, Radiation Therapy Treatment
• Manufacturer (Section D): Elekta Solutions AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer (Section G): Elekta Solutions AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 50880207
• Report Number: 3015232217-2026-00031
• Device Sequence Number: 13246749
• Product Code: MUJ
• UDI-Device Identifier: 07340201500064
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K22323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Lot Number: 6.2.3.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown