FUJIFILM Healthcare Americas Corporation

4 FDA enforcement actions

4 Total Recalls

0 Class I

4 Class II

0 Class III

Firm Details

Product Types: device
States: MA

All Recalls

Class II: Risk 01/09/2026 device

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 be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
Class II: Risk 09/15/2025 device

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 II: Risk 06/11/2025 device

Devices had an unapproved slabbing software function enabled for use.
Class II: Risk 02/11/2025 device

The incorrect computed patient age is showing in VX for patients less than 3 months old.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.