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

Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
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 dose displayed incorrectly during the calibration process.
Additional Manufacturer Narrative
H11 updated: the customer reported that the dose displayed incorrectly during the calibration process.The investigation was completed by conducting a thorough evaluation of the products and the reported information.During dose calibration process on 6fff energy, the reference values displayed were wrong.Because this issue is experienced during calibration, it can be rectified prior to clinical treatments being delivered.Calibration is part of the quality assurance checks which are done to ensure that the system is working as intended before delivering clinical treatments, which is what happened in this instance.The root cause for the incorrect reference values in this instance could not be determined because it was not possible to retrieve the logs required from the time period of the incident.The investigation determined that this issue is no risk - detectable prior to use.

• 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 SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 21534420
• Report Number: 3015232217-2025-00002
• Device Sequence Number: 20743929
• Product Code: IYE
• UDI-Device Identifier: 05060191071574
• UDI-Public: 05060191071574
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K210500
• 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): 06/05/2025

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?: Yes
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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