MAUDE Adverse Event Report: Varian Medical Systems Imaging Laboratory GmbH ARIA Radiation Therapy Management

Model Number	HIT0799
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer had reported a hospital wide cyber security breach on (b)(6) 2026.
Additional Manufacturer Narrative
The hospital system was hit with a ransomware attack.Attack occurred on july 27 2026.It affected the entire hospital system.They could restore the aria servers from backups that they took just before the cyberattack.By the 17th of august, 2026, 5 eclipse workstations and their truebeam machines were tested and working again.Customer was able to resume treatment of the patients on the (b)(6) 2026 successfully.While the hospital was not treating, some patients' treatments were transferred to other facilities.The patients that had ongoing treatments were given the option to have their treatments in another facility or wait until the hospital is treating again.This was also true for some new patients that were only starting their treatments.No allegation of malfunction is made against aria applications related to the attack, which are determined to be working as intended.Reporting due to patient treatment delay.There is no claim of direct injury to any patient, but treatment interruption for greater than two weeks has the potential to decrease efficacy of radiation treatment.

• 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--102 ; +1(650)424-6833
• MDR Report Key: 50412341
• Report Number: 3010123525-2026-00001
• Device Sequence Number: 10489675
• Product Code: IYE
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: HIT0799
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• 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