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 | A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. |
| Product | RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator. |
| Quantity | 7 systems |
| Distribution | U.S.: CA, CT, NJ, OR, PA and TX No O.U.S. |
| Initiated | 2024-04-16 |
| Classified | 2024-05-30 |
| Recall number | Z-1933-2024 |
| 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-1933-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94533/
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