Class II — Reflexion Medical, Inc.
| Recalling firm | RefleXion Medical, Inc. |
|---|---|
| Registered facility | REFLEXION MEDICAL, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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). |
| 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 dete… |
| Quantity | 11 |
| Distribution | U.S. Nationwide distribution in the states of CA, CT, LA, NJ, OR, PA, and TX. |
| Initiated | 2025-07-22 |
| Classified | 2025-09-02 |
| Recall number | Z-2486-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Reflexion Medical, Inc. (Z-2486-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97311/
Alerts for RefleXion Medical, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.