MAUDE Adverse Event Report: RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION; RADIATION THERAPY TREATMENT PLANNING SYSTEM

Model Number	RAYSTATION/RAYPLAN 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RAYPLAN 2
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
No event occurred.No patients were affected.There is only a potential health hazard discovered by the manufacturer.This issue concerns the voxelwise worst clinical goals in the robust evaluation module of raystation 8b, 9a, 9b, 10a and 10b.Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal.An additional issue was found un the contouring when the spacing between slices is less than or equal to 1 mm, present in raystation/rayplan versions from 6 up to 10a.
Additional Manufacturer Narrative
A software implementation error has been identified.Robust evaluation is used to evaluate if a proposed treatment plan is robust against variations in e.G.Patient setup in potential scenarios.One of the methods is to define clinical goals that evaluate robustness.Clinical goal results are displayed with a numerical value and a color coded passed/failed indication."voxelwise worst" goals evaluate the voxelwise min or max dose over all scenarios.If a "voxelwise worst" type clinical goal is updated, the user interface will not be correctly updated.In raystation 8b, neither the clinical goal value nor the passed/failed result will be updated.In raystation 9a and higher, the passed/failed indication will be updated and always display a correct result, but the numerical value will not.The display will be correct after switching from clinical goals view to scenario view and back.In the event that a clinical decision is based on the incorrect display, this could lead to the approval of an inappropriate dose plan.This could lead to local over-dose in a risk organ or local under-dose to the target.
Event or Problem Description
Follow up of report rsa: mdr 3010034862-2023-00010 (b)(6) voxelwise worst clinical goal not updated.No event occurred.No patients were affected.There is only a potential health hazard discovered by the manufacturer.This issue concerns the voxelwise worst clinical goals in the robust evaluation module of raystation 8b, 9a, 9b, 10a and 10b.Evaluation of a clinical goal for the voxelwise worst dose distributions may be misleading after editing the clinical goal.An additional issue was found un the contouring when the spacing between slices is less than or equal to 1 mm, present in raystation/rayplan versions from 6 up to 10a.

• Brand Name: RAYSTATION
• Common Device Name: RADIATION THERAPY TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): RAYSEARCH LABORATORIES AB (PUBL); eugeniavaegen 18c; stockholm, se, 11368 ; SW 11368
• Manufacturer (Section G): RAYSEARCH LABORATORIES AB (PUBL)EUGENIAVAEGEN 18C,; eugeniavagen 18c; stockholm, 11368 ; SW 11368
• Manufacturer Contact: david hedfors ; eugeniavagen 18c; stockholm, 11368 ; SW 11368
• MDR Report Key: 16468458
• Report Number: 3010034862-2023-00010
• Device Sequence Number: 7671523
• Product Code: MUJ
• UDI-Device Identifier: 07350002010310
• UDI-Public: 07350002010310
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K210645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025
• Report Date (Section F): 03/02/2023

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
• Device Expiration Date: 12/23/2025
• Device Model Number: RAYSTATION/RAYPLAN 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RAYPLAN 2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2021
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 87977
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/02/2023