Every recall we track for FUJIFILM Healthcare Americas Corporation — 24 in all — plus the complaints and injury reports the public filed about them.
FUJIFILM recalls software version v7.4.310 for inaccurate ruler measurements in radiological image processing systems. Affected units include specific serial numbers and UDI codes.
FUJIFILM Healthcare recalls specific models of X-ray high-voltage generators (CH-200) due to risk of overheating and smoke after power cut. Affected units have unique serial numbers and versions.
FUJIFILM Healthcare recalls CH-200 X-ray units with specific model numbers due to risk of X-ray tube shaft breaking during operation, potentially causing injury. Affected units include model versions 566-16130-23, 566-16130-31, and 566-16130-33.
FUJIFILM Healthcare recalls ASPRIRE Cristalle Mammography Systems with unapproved slabbing software. Affected units have specific model numbers and UDI codes. No remedy provided in official notice.
FUJIFILM recalls Synapse PACS software versions 7.4.000-7.4.200 due to incorrect patient age calculations for infants under 3 months old. Affected users should verify their software version.
FUJIFILM Healthcare recalls Noblus AC adapters for ultrasound systems that may overheat and cause smoke if power cables are frequently plugged in and out.
FUJIFILM recalls specific FDR Visionary Suite models for potential tube rupture causing patient injury during skull or spine imaging. Affected units have unique serial numbers and model numbers listed in the recall notice.
FUJIFILM Healthcare recalls Synapse PACS software version 7.2.200 due to incorrect breast cancer measurements when used with certain imaging. Affected users should contact for updates.
FUJIFILM Healthcare recalls Synapse PACS software version 7.3.000 due to incorrect breast measurements when using Breast Tomo Series. Affected units may need correction to ensure accurate imaging results.
FUJIFILM Healthcare recalls Synapse PACS software version 7.1.000US due to incorrect breast measurements when using specific imaging features. Affected users should contact for updates.
FUJIFILM Healthcare recalls Synapse PACS software version 7.2.000 due to potential incorrect breast cancer measurements when used with certain imaging. Affected users should contact the company for updates.
FUJIFILM Healthcare recalls Synapse PACS software version 7.1.000 due to incorrect breast measurements when combining certain imaging results. Affected users should contact for updates.
FUJIFILM Healthcare recalls Synapse PACS software version 7.2.100 due to potential incorrect breast cancer measurements when used with specific imaging. Affected users should contact the company for updates.
FUJIFILM Healthcare recalls Synapse CV 6. with AR software versions 6.0.0-6.2.2 for potential misdiagnosis from incorrect left ventricle mass calculations. Affected users should contact the manufacturer for details.
FUJIFILM Healthcare recalls specific versions of Synapse Cardiology PACS software due to potential incorrect left ventricle mass calculations, which could lead to misdiagnosis or incorrect treatment.
FUJIFILM Healthcare recalls mobile x-ray systems with default adult chest exposure settings that may cause incorrect imaging. Affected units have specific serial numbers from all shipments.
FujiFilm recalls digital mobile X-ray systems (DR-XD1000) due to risk of serious injury from a breakable arm component. Affected units have serial numbers ending 0001-1993. Contact for repair or return.
FUJIFILM Healthcare recalls Surpria software versions V3.11 and V3.22 due to scanning errors that may require additional radiation exposure for patients. Affected units have specific serial numbers and UDI codes.
FUJIFILM Healthcare recalls SCENARIA View software versions V1.08-V1.09D due to image reconstruction errors that may require additional radiation exposure during scans.
FUJIFILM recalls Surpria 64 software versions V3.11 and V3.22 due to potential radiation exposure from improper image reconstruction during scans. Affected units may require additional scans.
FujiFilm recalls Arietta 65 ultrasound software versions V1.0 through V4.0.0 due to incorrect calculation of Effective Regurgitant Orifice Area (EROA) when used with Fujifilm transducers, potentially leading to inaccurate heart flow measurements.
FujiFilm recalls Arietta 750 ultrasound software versions V1.0.0 to V2.1.3 due to incorrect measurements for mitral regurgitation and valve function. Affected units may display wrong results during cardiac scans.
Recalled FujiFilm Lisendo 880 ultrasound software versions V1.0 to V4.1.3 may display incorrect mitral regurgitation flow and valve measurements. Affected units have specific serial numbers.
Recalled FujiFilm Arietta 850 ultrasound systems with specific software versions (V1.0.0 to V4.1.3) may show incorrect mitral regurgitation and valve measurements, risking inaccurate cardiac diagnoses.
