Recall Z-2486-2025— Reflexion Medical, Inc.

Class II FDA medical device recall by Reflexion Medical, Inc., initiated 2025-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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)..

Recalling firm

Reflexion Medical, Inc.

Classification

Class II

Status

Ongoing

Initiated

2025-07-22

Firm location

Hayward, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.