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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.
Recalled March 26, 2025 · FDA recall Z-1407-2025 · FUJIFILM Healthcare Americas
Hazard
The incorrect computed patient age is showing in VX for patients less than 3 months old. · FDA Class II
Units
104 units (69 US, 35 OUS)
Sold at
Domestic: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MN, MO, MS, NC, NJ, NY, OH, OK, OR, TN, TX, VT, WA, WI, WV, WY. International: Australia, Belgium, Brazil, France, Germany, Portugal, UK
Description
The incorrect computed patient age is showing in VX for patients less than 3 months old.
Product
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.
Manufacturer(s)
FUJIFILM Healthcare Americas Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →