MAUDE Adverse Event Report: REFLEXION MEDICAL INC REFLEXION MEDICAL RADIOTHERAPY SYSTEM; RXM1000

Model Number	RXM1000
Medical Device Problem Code	Program or Algorithm Execution Problem (4033)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During routine testing of the reflexion medical radiotherapy system (rmrs) on site at reflexion, the following failure mode was identified.When performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location.This was determined to be the result of a software defect associated with the calculation and communication of cumulative virtual roll offsets between components in the system.It was determined that a very small number of affected treatment sessions may have a displacement of as much as 5mm from the intended location for the delivered dose volume.A displacement of 5mm or higher may result in clinically significant dosimetric errors (potentially as high as 10% to 20% underdose).Using information available in the system logs to investigate the impact of the above problem, the following case was identified as meeting a greater than 5mm displacement representing a potentially significant dosimetric error.The patient plan consisted of 30 gy to be delivered in 3 fractions, with a 10 gy plan dose per fraction.In 1 of 3 fractions for this specific case, a potential dose displacement of 5.11mm was identified.The site's clinical team, with access to all the treatment information (e.G., dose distribution, target location, proximity of nearby organs at risk, etc.) evaluated the case and determined that no actual serious injury occurred.
Additional Manufacturer Narrative
A recall has been filed for this issue on 12-feb-2026 (res# (b)(4), recall number: z-1656-2026, reflexion report # (b)(4)).Reflexion continues to work with the site to complete the investigation into potential events.Reflexion has completed the root cause investigation for the capa opened and is in the process of implementing the proposed solution.

• Brand Name: REFLEXION MEDICAL RADIOTHERAPY SYSTEM
• Common Device Name: RXM1000
• Manufacturer (Section D): REFLEXION MEDICAL INC; 25881 industrial blvd; hayward CA 94545
• Manufacturer (Section G): REFLEXION MEDICAL INC.; 25881 industrial blvd; hayward CA 94545
• Manufacturer Contact: alicia wong ; 25881 industrial blvd; hayward, CA 94545 ; 6502399070
• MDR Report Key: 24760505
• Report Number: 3011716550-2026-00024
• Device Sequence Number: 13058252
• Product Code: QVA
• UDI-Device Identifier: 00860003983812
• UDI-Public: (01)00860003983812(11)230504
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN220014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: RXM1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown