RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator.
This recall is currently active, issued September 2, 2025. It was issued by Reflexion Medical, Inc..
- Company
- Reflexion Medical, Inc.
- Recall Initiated
- July 22, 2025
- Posted
- September 2, 2025
- Recall Number
- Z-2486-2025
- Quantity
- 11
- Firm Location
- Hayward, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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).
Distribution
U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.
Lot / Code Info
Model Number: RXM1000 UDI Codes that includes Serial Numbers: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012
Root Cause
Software change control
Action Taken
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