Every recall we track for Fujifilm Medical Systems U.S.A., Inc. — 18 in all — plus the complaints and injury reports the public filed about them.
Fujifilm recalls Synapse Cardiovascular software versions 6.0 to 6.2.1 due to potential patient ID reuse during database merges, which could lead to misidentification in medical records.
Fujifilm recalls Synapse PACS software versions 5.1 to 5.7.200 due to potential display of incorrect patient information in radiology systems.
Fujifilm Medical Systems recalls specific Wako TASWako i30 Chip Cassette units that may cause incorrect DCP and AFP-L3% measurements when used for certain tests.
Fujifilm recalls Wako HDL-C/LDL-C Calibrator (Lot EL62:9) due to incorrect concentration values on labels, which may lead to inaccurate cholesterol test results. Affected units should be checked for the specific lot number.
Fujifilm recalls PACS software versions 7.0.0 and 7.0.1 due to clinical reporting errors when ventricular traces are changed by different users. Affected users should check their software version and contact Fujifilm for updates.
Fujifilm recalls Synapse PACS software versions 5.1 and higher due to risk of displaying incorrect patient information or SUV values in medical imaging. Affected users should contact the manufacturer for updates.
Fujifilm recalls Synapse PACS Software Version 5.6.1 due to potential over-reporting of 3D Sphere MAX values in CT studies. Affected users should contact Fujifilm for guidance.
Fujifilm recalls specific versions of Synapse PACS software (5.5.x and 5.7.x) due to potential incorrect 3D Tomo slider bar markers, which could lead to misdiagnosis. Affected units have unique serial numbers listed.
Fujifilm recalls FDR Go Plus mobile X-ray systems due to potential Blue Screen of Death errors. Affected units have all serial numbers.
Fujifilm recalls FDR Go PLUS mobile X-ray systems with serial numbers MQ0001281001 to MQ00012: The braking mechanism may not engage when the handle is released, potentially causing unintended movement during use.
