The FDA has posted 5 enforcement recalls from FUJIFILM Healthcare Americas Corporation since 2025, none of them Class I (most serious). Most recent report: Sep 2, 2026.
Software issue may cause the ruler measurement to be inaccurate.
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…
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 to…
Devices had an unapproved slabbing software function enabled for use.
The incorrect computed patient age is showing in VX for patients less than 3 months old.
Firm name as filed with the FDA: “FUJIFILM Healthcare Americas Corporation”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.