RefleXion Medical, Inc.
4 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (4)
Registered facilities (1)
- REFLEXION MEDICAL, INC. FEI 3011716550 · CA
Recalls & enforcement
- Class IIOngoing2026-02-09Due 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 d…
- Class IIOngoing2025-07-22Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity).
- Class IIOngoing2024-04-16A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
- Class IITerminated2021-11-24Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS).
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “RefleXion Medical, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10078251-reflexion-medical-inc/
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