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

Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2026
Type of Reportable Event	Other
Event or Problem Description
The customer asked which tolerances are applied for isocentric couch rotation, gantry rotation and collimator rotation during beam interruption.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

• Brand Name: VERSA HD
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL,
• Manufacturer (Section D): Elekta Solutions AB; hagaplan 4; stockholm; sweden, 113 6 8; SW 113 68
• Manufacturer (Section G): Elekta Limited; cornerstone; london road; crawley, west sussex RH10 9BL; UK RH10 9BL
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 50450719
• Report Number: 3015232217-2026-00026
• Device Sequence Number: 13339853
• Product Code: IYE
• UDI-Device Identifier: 05060191071574
• UDI-Public: 05060191071574
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K252188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• 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: 07/04/2025
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2026
• 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