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

Medical Device Problem Codes	Arcing of Electrodes (2289); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reported arcing in the magnet bore.
Additional Manufacturer Narrative
The customer reported arcing in the magnet bore.The investigation was completed by conducting a thorough evaluation of the product and the reported information.On (b)(6) 2025, during radiation therapy treatment of a patient, a scan abort occurred, triggered by a risk control measure that aborts the scan if a current error is detected in the gradient amplifier.The scan was restarted after this abort.During scanning the user noticed smoke emerging from the system covers via the patient observation cameras, and the patient triggered the nurse call via the handheld switch/button.The user evacuated the patient from the treatment room.No injury has been reported.The marlin 1.5t is an integrated component of the elekta unity mr-linac system.Philips is the manufacturer of the marlin 1.5t.Elekta is the legal manufacturer of the unity mr-linac system and has overall responsibility for the finished medical device.The root cause has been identified by philips as follows: the connections between the busbars and the gradient coil were not installed according to the instructions.Stainless steel nord-lock washers have been found between the busbars and the gradient coil terminals instead of on top of the busbar, which facilitated the overheating and loosening of the connections.Eventually the conducting path between the busbars and gradient coil terminals was reduced to an extent where arcing occurred, which led to the development of smoke and thermal damage to the system.Elekta performed a risk assessment and assessed the severity of harm to be "serious" and probability to be "implausible".The risk assessment concluded that the risk is considered low.An important safety notice (fco) 200-01-801-012 was submitted to all affected customers on 04/04/2023.This was then superseded on 20/06/2023 with fco 200-01-801-013 and then on 14/08/2025 this fco was superseded with fco 200-01-801-016.

• Brand Name: ELEKTA UNITY
• 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; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 22139632
• Report Number: 3015232217-2025-00015
• Device Sequence Number: 15234397
• Product Code: IYE
• UDI-Device Identifier: 05060191071598
• UDI-Public: 05060191071598
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K212114
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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