RefleXion Medical Radiotherapy System — Class II medical device recall Z-0470-2022
Terminated recall by Reflexion Medical, Inc., reported 2022-01-19, distributed nationwide. Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation speci
| Recall number | Z-0470-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reflexion Medical, Inc., Hayward, CA, United States |
| Recall initiated | 2021-11-24 |
| Classified | 2022-01-10 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2024-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 3 devices |
| UPC / GTIN / UDI-DI | 00860003983805 |
| Model numbers | RXM1000 |
Product
RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
Reason for recall
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0470-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.