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

Model Number	RAYCARE 3B, RAYCARE 4A
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
No serious event occurred.No patients were affected.A customer noticed a malfunction after upgrade of the system.This issue was found in the raycare upgrade.Message body from patient related messages created in raycare 3b, raycare 4a will be lost when upgrading from raycare 2 to raycare 3b or later.
Additional Manufacturer Narrative
A software implementation error in raycare 3a has been identified.When upgrading from raycare 2 to raycare 3a an error is introduced.The error however does not manifest until an upgrade to 3b or later is done.Raycare 3a can be safely used.If, the missing message body text contains information that is intended to influence treatment planning or instructions on patient care, the treatment may not be performed as intended.
Event or Problem Description
Follow-up of report rsa: mdr 3010034862-2023-00012 75198 rc message contents lost.No serious event occurred.No patients were affected.A customer noticed a malfunction after upgrade of the system.This issue was found in the raycare upgrade.Message body from patient related messages created in raycare 3b, raycare 4a will be lost when upgrading from raycare 2 to raycare 3b or later.

• 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,; eugeniavagen 18c; stockholm, 11368 ; SW 11368
• Manufacturer Contact: david hedfors ; eugeniavagen 18c; stockholm, 11368 ; SW 11368
• MDR Report Key: 16492263
• Report Number: 3010034862-2023-00012
• Device Sequence Number: 6296941
• Product Code: MUJ
• UDI-Device Identifier: 07350002010341
• UDI-Public: 07350002010341
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025
• Report Date (Section F): 03/06/2023

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: Health Professional
• Device Expiration Date: 06/26/2025
• Device Model Number: RAYCARE 3B, RAYCARE 4A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/10/2021
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 87471
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/06/2023