FUJIFILM Healthcare Americas Corporation recalls

4 recalls on record · latest: January 9, 2026

Official U.S. recall history for FUJIFILM Healthcare Americas Corporation, compiled from official government records.

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FDR Visionary Suite recalled over fire hazard

January 9, 2026 · Medical device recalls Moderate risk It was found that the contacts of the electromagnetic contactors used inside th…

FUJIFILM Healthcare Americas Corporation recalls FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31, (3) 566-16130-33

September 15, 2025 · Medical device recalls Moderate risk It was found that the shaft for mounting the X-ray tube unit on the support may…

FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosyn…

June 11, 2025 · Medical device recalls Moderate risk Devices had an unapproved slabbing software function enabled for use.

FUJIFILM Healthcare Americas Corporation recalls Synapse 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.

February 11, 2025 · Medical device recalls Moderate risk The incorrect computed patient age is showing in VX for patients less than 3 mo…