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.
- Recall date
- February 11, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1407-2025
- FDA classification
- Class II
- Brand / firm
- FUJIFILM Healthcare Americas Corporation
- Sold / distributed
- 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
Why it was recalled
The incorrect computed patient age is showing in VX for patients less than 3 months old.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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