Facility

HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION

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

Key facts

1recalls · worst Class II

3inspections · worst VAI

—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)	3003993895
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	2535 Augustine Dr Santa Clara, CA, US 95054
Registration status	Active · expires 2026
Parent company	Hitachi High-Tech America, Inc. Radiation Therapy Division (owner-operator 10094162)

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

System, Radiation Therapy, Charged-Particle, Medical
Product code LHN (opens in a new tab) · Class II · Radiology · 21 CFR 892.5050

Recalls & enforcement

Class IIOngoing2024-05-27
During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

FDA inspections (3)

NAI2026-08-07
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act
VAI2022-03-04
Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act · citations posted
NAI2020-03-09
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted

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 Hitachi High-Tech America, Inc. Radiation Therapy Division

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. “HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION (FEI 3003993895) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003993895-hitachi-high-tech-america-inc-radiation-/

Not open yet

Alerts for HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.