MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB LEKSELL GAMMAPLAN; RADIONUCLIDE RT TREATMENT PLANNING SYSTEM

Lot Number	11.4.1
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to an administrative error, the report was originally submitted under., which was an incorrect/incomplete reference number.The correct reference should have been.Therefore, this report has been submitted as an initial and final to correct the reference number.H6 updated.H11 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that an obsolete stereotactic reference was used for treatment.It was ascertained that a treatment plan was created using frameless mri images, g-frame fixation, and cone beam computed tomography (cbct) as the stereotactic reference.During the planning process, the customer elected to reposition the frame and acquired a new cbct.However, due to a use error, the treatment plan was not correctly updated to reflect the new frame position.As a result, the treatment was delivered based on the previous frame placement.The plan had been approved and partially delivered before the operator identified the discrepancy and paused the treatment.The system worked as designed and intended.Elekta have not been provided with information regarding the patient's condition.An important field safety notice (100-01-102-019) will be sent to all affected customers from 17 december 2025 (elekta reference #: (b)(4)).
Event or Problem Description
The customer reported that an obsolete stereotactic reference used for treatment.

• Brand Name: LEKSELL GAMMAPLAN
• Common Device Name: RADIONUCLIDE RT TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, sweden 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: 23877055
• Report Number: 3015232217-2025-00063
• Device Sequence Number: 4771222
• Product Code: MUJ
• UDI-Device Identifier: 07340201502136
• UDI-Public: 07340201502136
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K232854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Lot Number: 11.4.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 12/23/2025
• Date Device Manufactured: 01/25/2024
• 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