Facility

FUJIFILM Healthcare Americas Corporation

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

Key facts

2recalls · worst Class II

1inspections · 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)	1528028
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	1959 Summit Commerce Park Twinsburg, OH, US 44087
Registration status	Active · expires 2026
Parent company	FUJIFILM Healthcare Americas Corporation (owner-operator 10082284)
Brand names	C9150LA

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (3)

System, Imaging, Pulsed Doppler, Ultrasonic
Product code IYN (opens in a new tab) · Class II · Radiology · 21 CFR 892.1550
Transducer, Ultrasonic, Diagnostic
Product code ITX (opens in a new tab) · Class II · Radiology · 21 CFR 892.1570
System, Imaging, Pulsed Echo, Ultrasonic
Product code IYO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560

Recalls & enforcement

Class IIOngoing2021-10-14
Diagnostic ultrasound system with the specified software version and used in conjunction with a Fujifilm (formally Hitachi) transducer does not display the measurement results correctly with two cardiology measurement functions: Mitral Regurgitation Flow (MR Flow) Measurement; Mi…
Class IIOngoing2021-10-14
When the ultrasound system is used in combination with a Fujifilm (formally Hitachi) transducer, there is an error in the calculation formula of Effective Regurgitant Orifice Area (EROA) when you perform MR Flow combined with Left Ventricular Outflow Tract Flow (LVOT Flow) after …

FDA inspections (1)

VAI2017-02-06
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · 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 FUJIFILM Healthcare Americas Corporation

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. “FUJIFILM Healthcare Americas Corporation (FEI 1528028) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1528028-fujifilm-healthcare-americas-corporation/

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