MAUDE Adverse Event Report: ACCURAY, INC ACCURAY PRECISION TREATMENT PLANNING SYSTEM; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

Model Number	PRECISION
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A simulation plan was initially created using a small tumor contour.Later, the doctor requested a larger volume, prompting a second simulation plan.After loading the second plan, the system continued using the original simulation plan, causing data mismatches between ucc and precision.Attempts to fix the issue included creating a third plan without simulation and re-importing ct scans with new uids.An engineering investigation was opened under an anomaly to assess associated risks.No patients were harmed, and the investigation is ongoing.
Event or Problem Description
The system kept using the old simulation structures, and not the one used in the plan.
Additional Manufacturer Narrative
Despite extensive testing, it was not possible for the manufacturer to reproduce the observed incident, leading to the conclusion that it occurred under a very specific sequence of events.The manufacturer is also not aware of a similar incident.Nevertheless, the data impacted in the simulation plan that caused problems for the user were found to be non patient critical (they are used as a display support, and do not adjust or affect planning data or treatment-time tracking), and are therefore not likely to contribute to a serious injury.Note: code 4316 was used because we could not identify a code for a non-reproducible malfunction.This issue was not an adverse event.

• Brand Name: ACCURAY PRECISION TREATMENT PLANNING SYSTEM
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ACCURAY, INC; 1209 deming way; madison WI 53717
• Manufacturer (Section G): ACCURAY, INC; 1209 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1240 deming way; madison, WI 53717 ; 6088242971
• MDR Report Key: 23651680
• Report Number: 3003873069-2025-00005
• Device Sequence Number: 13235738
• Product Code: MUJ
• UDI-Device Identifier: 00811376030221
• UDI-Public: 0100811376030221112109211236
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K212794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: Health Professional
• Device Model Number: PRECISION
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/31/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/27/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown