MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Lot Number	VERSION 3.1.3.3
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.H4: manufacturing date is not on the label, but it is known so field h4 has been completed with this information.
Event or Problem Description
The customer reported the wrong 2d mosaiq shift for beams at couch angles.
Additional Manufacturer Narrative
The investigation found that if the user has defined their mosaiq machine characterization (mac) file for a device that does not reflect the iec 61217 coordinate system, and a non-zero couch angle is used for treatment, it is possible that the image review application in mosaiq is incorrectly computing shifts.If the incorrect shift was not detected and used for treatment, mistreatment could occur.Elekta performed a risk assessment and assessed the severity to be "serious" and probability to be "remote" if this issue were to re-occur.The route cause was traced to a problem with the software coding.During the implementation of the image review application for particle therapy systems in the 3.1.2 release, the concept of the 'non-zero patient support angle' was introduced.However, the requirements did not address handling the patient support angle at a non-iec 61217 scale.As a result, the design, testing, and safety reviews did not take this into consideration.If the incorrect shift was not detected and used for treatment, mistreatment could occur.An important field safety notification (ifsn: 371-01-msq-019 ) was distributed to impacted customers on 15/01/2025 to notify the customer about the issue and the recommended user action until the fix is available a field safety modification was released on 14/03/2025 detailing the corrective actions available to customers.Elekta service representatives will contact affected customers to arrange for the modification to be completed.

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 20924913
• Report Number: 3015232217-2024-00033
• Device Sequence Number: 5107737
• Product Code: IYE
• UDI-Device Identifier: 07340201500026
• UDI-Public: (01)07340201500026(10)3.1.3.3
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K203172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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?: No
• Operator of Device: Health Professional
• Device Lot Number: VERSION 3.1.3.3
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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