Facility

REFLEXION MEDICAL, INC.

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3011716550
Establishment type	Manufacture Medical Device
Location	25881 Industrial Blvd Hayward, CA, US 94545
Registration status	Active · expires 2026
Parent company	RefleXion Medical, Inc. (owner-operator 10078251)
Brand names	RefleXion Medical Radiotherapy System, Reflexion X2

Activity by year

Recalls (4)
Inspections (1)

Devices registered here (3)

Fludeoxyglucose F18-Guided Radiation Therapy System
Product code QVA (opens in a new tab) · Class II · Radiology · 21 CFR 892.5060
System, Planning, Radiation Therapy Treatment
Product code MUJ (opens in a new tab) · Class II · Radiology · 21 CFR 892.5050
Accelerator, Linear, Medical
Product code IYE (opens in a new tab) · Class II · Radiology · 21 CFR 892.5050

Recalls & enforcement

Class IIOngoing2026-02-09
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 d…
Class IIOngoing2025-07-22
Due 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 IIOngoing2024-04-16
A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
Class IITerminated2021-11-24
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).

FDA inspections (1)

NAI2024-02-28
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by RefleXion Medical, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “REFLEXION MEDICAL, INC. (FEI 3011716550) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011716550-reflexion-medical-inc/

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