MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS IMAGING LABORATORY GMBH ARIA RADIATION THERAPY MANAGEMENT

Model Number	HIT4410
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the entire hospital network failure, all radiation therapy patients were referred to other centers for treatments.The radiation therapy department was fully electronic at the time of network failure, and they did not have paper copies of treatments.This means previous patient data was also lost.The patients did need to be replanned by the other center when they were referred.If patients treated prior to the network failure return for treatment, no data of previous treatment would be available.The loss of patient data has the potential to complicate or delay the treatment planning of future radiation treatments, should patients return for care.We are actively working with the customer to rebuild their system and bring it back online.There is no claim of direct injury to any patient, we are reporting this due to loss of patient data.
Event or Problem Description
Customer reported cyber attack of their entire hospital system.

• Brand Name: ARIA RADIATION THERAPY MANAGEMENT
• Common Device Name: ARIA RADIATION THERAPY MANAGEMENT
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS IMAGING LABORATORY GMBH; taefernstrasse 7; daettwill 05405 ; SZ 05405
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 22983915
• Report Number: 3010123525-2025-00003
• Device Sequence Number: 21067408
• Product Code: IYE
• UDI-Device Identifier: 00856100006110
• UDI-Public: 00856100006110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: HIT4410
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/05/2025
• 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