MAUDE Adverse Event Report: Elekta Solutions AB MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Lot Number	Version 3.2.4.1
Medical Device Problem Codes	Computer Software Problem (1112); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Other

• 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: 50138982
• Report Number: 3015232217-2026-00023
• Device Sequence Number: 18427520
• Product Code: IYE
• UDI-Device Identifier: 07340201500071
• UDI-Public: (01)07340201500071(10)3.2.4.1
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K223229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Other
• Device Lot Number: Version 3.2.4.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2026
• 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