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. — FDA record Z-1407-2025

What the record says

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.

Reason

The incorrect computed patient age is showing in VX for patients less than 3 months old.

Classification

Class II

Recalling firm

FUJIFILM Healthcare Americas Corporation

Quantity

104 units (69 US, 35 OUS)

Agency-reported status

Ongoing

Source record identifier

Z-1407-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

• Arkansas
• Arizona
• California
• Colorado
• Connecticut
• Florida
• Georgia
• Hawaii
• Illinois
• Indiana
• Kansas
• Kentucky
• Louisiana
• Massachusetts
• Minnesota
• Missouri
• Mississippi
• North Carolina
• New Jersey
• New York
• Ohio
• Oklahoma
• Oregon
• Tennessee
• Texas
• Vermont
• Washington
• Wisconsin
• West Virginia
• Wyoming

Dates in the source

Report date

Mar 26, 2025

Recall initiation date

Feb 11, 2025

Center classification date

Mar 20, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.