Reflexion Medical, Inc.: Device Recall

Recall #Z-2486-2025 · 07/22/2025

Class II: Risk

Recall Details

Recall Number
Z-2486-2025
Classification
Class II
Product Type
Device
Recalling Firm
Reflexion Medical, Inc.
Status
Ongoing
Date Initiated
07/22/2025
Location
Hayward, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11

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).

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.

Distribution Pattern

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

Other Recalls by Reflexion Medical, Inc.

View all recalls by Reflexion Medical, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.