FUJIFILM Healthcare Americas Corporation
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for FUJIFILM Healthcare Americas Corporation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-02-11FDA-DeviceClass IIFDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
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.
- 2025-10-15FDA-DeviceClass IIFDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33
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.
- 2025-08-06FDA-DeviceClass IIASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Devices had an unapproved slabbing software function enabled for use.
- 2025-03-26FDA-DeviceClass IISynapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
The incorrect computed patient age is showing in VX for patients less than 3 months old.
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