RefleXion X1 Model RXM1000 recallZ-2486-2025 · Reflexion Medical, Inc. · initiated Jul 22, 2025

Why it was recalled

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).

FDA root cause category: Software change control

What the company is doing

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 [email protected]

Recall details

Recall number

Z-2486-2025

Status

Open, Classified

Initiated by the company

Jul 22, 2025

Posted by the FDA

Sep 2, 2025

Recalling firm

Reflexion Medical, Inc.

Quantity

11

Product code

QVA

Distribution

U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX.

Product description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• RefleXion Medical Radiotherapy System RXM1000

  Reflexion Medical, Inc. · Fludeoxyglucose F18-Guided Radiation Therapy System
  3 recalls36 reports