Reflexion Medical, Inc. recalls RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)008…

Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).

On 07/22/2025, the firm sent an "Urgent Medical Device Recall Safety Notification (Correction)" Letter to customer informing them that RefleXion is initiating a Recall (Correction) of the RefleXion X1 System (model RXM1000). An issue has been identified with a configuration setting for the maximum number of fractions that can be delivered within a specified time period. The system should be configured to allow the delivery of up to two (2) fractions, including completion of partial fractions, for each treatment plan within a 12-hour period. As a result of this issue there is a potential to unintentionally administer more than two treatments in a 12-hour period, potentially leading to serious toxicity. Customer are instructed to: 1) Acknowledge receipt of the email by signing and returning the attached Consignee Acknowledgment Form at their earliest convenience. 2) Until the configuration setting is corrected, RefleXion Medical advises users to employ current radiation therapy procedures within the clinic to perform daily checks of treatment session records for radiation therapy patients to prevent delivery of unintended fractions. 3) It is requested that customers post this notification on or near the RefleXion Medical RXM1000 system until this issue can be resolved. For questions or assistance - email support@reflexion.com

• FDA enforcement recordOfficial FDA database entry for Z-2486-2025
• FDA device classification · QVAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5060The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Reflexion Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.