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

Lot Number	VERSION 2.83.025
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	01/09/2026
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 that mosaiq is not recording the dose.
Additional Manufacturer Narrative
D3 updated.G3 updated.H11 updated: the customer reported that mosaiq is not recording the dose.The investigation was completed by conducting a thorough evaluation of the product and the related information.On (b)(6) 2026, field 1 was entered for treatment.During treatment delivery a machine error occurred, and the machine went offline briefly.An abnormal termination message is noted in the audit log.At the time of the message, mosaiq was aware that a count of 260.2 mu had been delivered to field 1.However, the full dose of 354.5mu had been delivered and the user was aware of this.Mosaiq displayed the value 260.2mu on the abnormal termination form which also provided three options to the user: a) the treatment information is correct.Record the treatment.B) monitor units were delivered, but the value is not correct.Manually record the treatment.C) no monitor units were delivered.Exit the field and do not record the treatment.The users selected the first option, and 260.2 mu was recorded.The user later entered a manual recording for the remaining 94.3 mu, completing the prescribed 354.5 mu to field 1.The user knew the full mu had been delivered and the number of mu delivered was different than proposed on the abnormal termination form, so option b) would have been the more appropriate choice.Mosaiq is working as intended.There was no patient mistreatment.

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale CA 94086
• 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: 24276076
• Report Number: 2950347-2026-00003
• Device Sequence Number: 18215101
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.025
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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 2.83.025
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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