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 | 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. |
| Product | RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 |
| Quantity | 12 |
| Distribution | US: CA, TX, PA, CT, NJ, OR, LA, OH |
| Initiated | 2026-02-09 |
| Classified | 2026-03-27 |
| Recall number | Z-1656-2026 |
| 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-1656-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98518/
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