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

Medical Device Problem Code	Grounding Malfunction (1271)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
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
Elekta have identified a safety issue relating to the modulator discharge rod.
Additional Manufacturer Narrative
H11 updated: the investigation was completed by conducting a thorough evaluation of the products and the reported information.Elekta production has identified a safety issue relating to the modulator discharge rod, where the supplier has been fitting the crimp in the crimp tool back to front.The safety discharge rod earth lead pulled out with ease with poor-quality workmanship which could lead to possible safety implications.Not all crimps pull off easily, but stock has been found with crimps fitted in reverse.There is no clinical impact for the clinical user or patient however there is a possible safety issue for the field service engineer (fse) when completing service activities: the fse uses the ht discharge rod to fully discharge the voltage capacitor.Once the fse has completed the procedure using the discharge rod, the fse will start to work on the system around the ht and rf assembly.If the discharge rod is not fully connected to the ground or not connected at all, the system will still be fully charged and the fse could receive an electric shock.Elekta have performed a risk assessment which concluded a severity of mortal and probability of remote which is classified as a medium risk.The root cause of the issue has been traced to the absence of clear work instructions for the crimping process, combined with insufficient training.In the absence of proper guidance, workers at the supplier's site have been crimping the cable in the incorrect orientation, which has directly led to the observed failures.An important safety notice (fco) 200-01-103-089 was submitted to all affected customers on 14 november 2025.Elekta released an important field safety modification (ifsm) in order to identify potentially faulty discharge rods and or crimping, the ifsm also includes procedures to verify the reliability of the affected device or to make replacements in the field where necessary.Note that emlas are manufacturered at the address listed in g1, but also at the following address, added here as there is only one address field in g1 for manufacturing site: elekta beijing medical systems, 21 chuang xin road 10229, beijing, china.

• Brand Name: ELEKTA MEDICAL LINEAR ACCELERATOR
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 11368 ; SW 11368
• 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: 23197719
• Report Number: 3015232217-2025-00065
• Device Sequence Number: 15810844
• Product Code: IYE
• UDI-Device Identifier: 05060191071550
• UDI-Public: 05060191071550
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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?: Yes
• Operator of Device: Other
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown