FDA-Device2025-03-26Class II
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.
FUJIFILM Healthcare Americas Corporation
Hazard
The incorrect computed patient age is showing in VX for patients less than 3 months old.
Sold states
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
Affected count
104 units (69 US, 35 OUS)
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1407-2025Don't want to check this manually?
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