RefleXion X1 Radiotherapy System Model RXM1000 Software version 2 — Class II medical device recall Z-1933-2024
Ongoing recall by Reflexion Medical, Inc., reported 2024-06-05, distributed in CA, CT, NJ, OR, PA, TX. A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
| Recall number | Z-1933-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reflexion Medical, Inc., Hayward, CA, United States |
| Recall initiated | 2024-04-16 |
| Classified | 2024-05-30 |
| Reported by FDA | 2024-06-05 |
| Distributed | CA, CT, NJ, OR, PA, TX |
| Quantity | 7 systems |
| UPC / GTIN / UDI-DI | 00860003983812 |
| Model numbers | RXM1000 |
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.
Reason for recall
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
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-1933-2024. 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.