RegWardenFDA facility compliance records
Company

FUJIFILM Healthcare Americas Corporation

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

Recalls by year

FDA actions on record by year2021: 2 recalls20172018201920202202120222023202420252026
  • Recalls (2)

Registered facilities (1)

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 …

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. “FUJIFILM Healthcare Americas Corporation — 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-10082284-fujifilm-healthcare-americas-corporation/

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