FUJIFILM Healthcare Americas Corporation

Activity by year

Devices registered here (2)

• Whole Slide Imaging System
  Product code PSY (opens in a new tab) · Class II · Pathology · 21 CFR 864.3700
• Digital Pathology Image Viewing And Management Software
  Product code QKQ (opens in a new tab) · Class II · Pathology · 21 CFR 864.3700

Recalls & enforcement

• Class IIOngoing2026-07-22
  Software issue may cause the ruler measurement to be inaccurate.
• Class IIOngoing2026-01-09
  It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot b…
• Class IIOngoing2025-09-15
  It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.
• Class IIOngoing2025-06-11
  Devices had an unapproved slabbing software function enabled for use.
• Class IIOngoing2025-02-11
  The incorrect computed patient age is showing in VX for patients less than 3 months old.
• Class IIOngoing2024-04-11
  Bolts on the CH-200 tube may rupture due to fatigue failure, causing the tube support to fall, could result in patient injury
• Class IIOngoing2024-04-11
  AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
• Class IIOngoing2024-01-10
  Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
• Class IIOngoing2024-01-03
  The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagnosis or incorrect treatment plan of a patient, resulting in long-term health con…
• Class IIOngoing2023-11-23
  When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions…
• Class IIOngoing2023-02-27
  Arm which holds the tube head in place is susceptible to breaking, if the device breaks it could potentially cause serious harm or injury to the patient and/or user.
• Class IIOngoing2022-07-12
  Error 00003050 or 00003052 may occur during scanning, the captured images will not be reconstructed and the Raw Data will not be displayed in the work list.result, may result in the need for additional scanning to capture the images properly for reconstruction, thereby exposing …

FDA inspections (1)

• NAI2017-11-17
  No Action Indicated · Compliance: 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.

Related

• 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)