MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. HALCYON; Linear Accelerator

Model Number	HAL2049
Medical Device Problem Code	Misassembled During Installation (4049)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury

• Brand Name: HALCYON
• Common Device Name: Linear Accelerator
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC.; 911 hansen way; palo alto CA 94304 -103
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304--102 ; +1(650)424-6833
• MDR Report Key: 50462598
• Report Number: 2916710-2026-00001
• Device Sequence Number: 10264286
• Product Code: IYE
• UDI-Device Identifier: 00857235006075
• UDI-Public: (01)00857235006075(11)230605
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HAL2049
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 08/26/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown