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

Lot Number	VERSION 2.86.084
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/04/2025
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.
Event or Problem Description
The customer reported that the xvi treatment center looked wrong.
Additional Manufacturer Narrative
D4: udi updated.H11: updated: the customer reported that the xvi treatment center looked wrong.An investigation was attempted by conducting an evaluation of the product and the reported information.The customer was contacted several times for data required to investigate the reported problem.Attempts to obtain additional information were unsuccessful.The case was opened stating the wrong isocenter (0, 0, 0) was imported into mosaiq.In the promote data window, it is clear that the isocenter values were not the same value for all fields in the plan since a ? was present and "inconsistent isocenter position" warning was visible.If the user chooses to promote the plan with the ? values, any existing isocenter values will be removed from the site setup.The user then has to manually select the iso center values desired for site setup.The customer was expected to select the isocenter in site setup ahead of treatment so the correct isocenter reference would be used to position the patient.The audit log shows "cbct: user continued operation despite isocenter mismatch." based on the information that was provided, mosaiq is working as intended.The actual mistreatment was due to use error.The data needed to complete a physics review to assess the impact of the actual mistreatment was not provided; therefore, a physics review cannot be completed for this incident.

• 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: 22724488
• Report Number: 3015232217-2025-00048
• Device Sequence Number: 8418390
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.86.084
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K183034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: VERSION 2.86.084
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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