MAUDE Adverse Event Report: ACCURAY, INC. RADIXACT TREATMENT DELIVERY SYSTEM; MEDICAL LINEAR ACCELERATOR

Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2025, during routine maintenance of the kv generator, the accuray field service engineer (fse) noticed a crack in the beam stop cradle.The cracked beam stop has been replaced at the site.There has been no injury associated with this event and the investigation is still on-going.
Event or Problem Description
Beam stop cradle has visible crack.
Additional Manufacturer Narrative
The fatigue testing of the cracked bracket for the system goes beyond the life expectancy of the radixact system.The results concluded no crack propagation.Static load testing confirmed the x factor (8) of safety was maintained on the brackets.

• Brand Name: RADIXACT TREATMENT DELIVERY SYSTEM
• Common Device Name: MEDICAL LINEAR ACCELERATOR
• 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: 22819803
• Report Number: 3003873069-2025-00003
• Device Sequence Number: 5713147
• Product Code: IYE
• UDI-Device Identifier: 00811376030009
• UDI-Public: 010081137603000911220308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K202412
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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