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 | Terminated |
| Reason | Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS). |
| Product | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000" |
| Quantity | 3 devices |
| Distribution | U.S. Nationwide distribution in the states of CA and TX |
| Initiated | 2021-11-24 |
| Classified | 2022-01-10 |
| Terminated | 2024-07-08 |
| Recall number | Z-0470-2022 |
| 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-0470-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89212/
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