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

Lot Number	VERSION 3.2.3.0
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H4: manufacturing date is not on the label, but it is known so field h4 has been completed with this information.H11: the manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer asked if it is possible to update a record in mosaiq, following a treatment where mosaiq indicates that the gantry did not start at 0.
Additional Manufacturer Narrative
H11 updated: the customer asked if it is possible to update a record in mosaiq, following a treatment where mosaiq indicates that the gantry did not start at 0.The investigation was completed by conducting a thorough evaluation of the products and the reported information.This case meets the exception scenario: communication error (any machine) including citrix.A communication error occurs and the treatment delivery is or is not recorded.Incident/problem reporting evaluation: the prescribed treatment is delivered, as intended; however, due to the communication error the linac may or may not transmit the treatment data to the sequencer application for recording.Review of the record and user notifications make clear to the user that the provided treatment is not recorded.The user will recognize the incorrect recording and either contact elekta product support for assistance or correct the errant recording.As the treatment is delivered as prescribed, no serious injury nor death occurs, nor would either be foreseeable if the event were to recur.The machine and audit logs from 12 march 2026 show that field 1.1 (arc) was selected for treatment around 09:32:07.When a field containing multiple control points (e.G.Vmat) is sent to the treatment machine, only the first control point is verified by mosaiq.The mosaiq sequencer confirmed that all settings including the gantry position had gone into tolerance before beam on, allowing the machine to enter a ready state.The audit log shows approximately a 7 second gap between 9:32:40 and 9:32:47 when all background processing stopped.The cause of the lapse in processing is unknown.Currently, mosaiq is only able to detect that a lapse in processing occurred and alert/record with the error but cannot say definitively what is causing the lapse.It was during this 7 second period that beam on began (09:32:43).This indicates that there was a delay or latency in capturing actual values at the initial beam on and is the reason a start gantry position of 354.3 was recorded.This is only a recording issue.With vmat the gantry is typically moving from the start, so if the beam on was not reported or detected immediately in mosaiq, the gantry had already moved away from its starting point in the initial point recorded.The logs confirm that the gantry started at 359.9 and the prescribed 285.5 mu to field 1.1 (arc) was fully delivered.At the end of treatment, the user received an application communications time out error, and completed the treatment recording via the abnormal termination window presented in mosaiq.It is not possible to amend the gantry position of the historic record through the user interface.There was no mistreatment.Mosaiq worked as intended.

• 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; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 24827261
• Report Number: 3015232217-2026-00009
• Device Sequence Number: 9168413
• Product Code: IYE
• UDI-Device Identifier: 07340201500071
• UDI-Public: (01)07340201500071(10)3.2.3.0
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K223229
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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?: No
• Operator of Device: Health Professional
• Device Lot Number: VERSION 3.2.3.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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