RefleXion X1 Radiotherapy System Model RXM1000 — Class II medical device recall Z-1656-2026
Ongoing recall by Reflexion Medical, Inc., reported 2026-04-08, distributed in CA, CT, LA, NJ, OH, OR, PA, TX. Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a r
| Recall number | Z-1656-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Reflexion Medical, Inc., Hayward, CA, United States |
| Recall initiated | 2026-02-09 |
| Classified | 2026-03-27 |
| Reported by FDA | 2026-04-08 |
| Distributed | CA, CT, LA, NJ, OH, OR, PA, TX |
| Quantity | 12 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00860003983812 |
| Model numbers | 800-00006-00, RXM1000 |
Product
RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Reason for recall
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose.
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-1656-2026. 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.