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

Model Number	RAYCARE 2C SP2, 2C SP3, 3A, 3A SP1, 3B, 4A
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A software malfunction was detected by a customer prior to treatment.No patients were affected.The first treatment fraction had been performed and was to be reviewed in oir.There was an error message saying that the review files were not available.User called support.It was verified in raycare pacs that data was indeed available.The treatment image was then opened in raycare image viewer and it was noticed that the image registration was not done with the planning image set.The registration object used was correct, but the registration was done on the wrong image set.The bug is that the sw selects the first image set with the same frame of reference, rather than selecting the planning image set.
Event or Problem Description
Follow-up of report rsl: mdr 3007774465-2023-00018 65340 rc offline image review.A software malfunction was detected by a customer prior to treatment.No patients were affected.The first treatment fraction had been performed and was to be reviewed in oir.There was an error message saying that the review files were not available.User called support.It was verified in raycare pacs that data was indeed available.The treatment image was then opened in raycare image viewer and it was noticed that the image registration was not done with the planning image set.The registration object used was correct, but the registration was done on the wrong image set.The bug is that the sw selects the first image set with the same frame of reference, rather than selecting the planning image set.
Additional Manufacturer Narrative
A software implementation error has been identified.In the event that a clinical decision is based on the incorrect image registration display, this could lead to inappropriate patient positioning for the next treatment fraction.This could lead to local over-dose in a risk organ and/or under-dose to target.

• Brand Name: RAYCARE
• 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; stockholm, se, 11368 ; SW 11368
• Manufacturer Contact: david hedfors ; eugeniavaegen 18c; stockholm, se, 11368 ; SW 11368
• MDR Report Key: 16498408
• Report Number: 3007774465-2023-00018
• Device Sequence Number: 17734122
• Product Code: MUJ
• UDI-Device Identifier: 07350002010341
• UDI-Public: 07350002010341
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K200487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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
• Device Expiration Date: 06/26/2025
• Device Model Number: RAYCARE 2C SP2, 2C SP3, 3A, 3A SP1, 3B, 4A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2020
• 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 86249
• Patient Sequence Number: 1
• Patient Sex: Unknown