FUJIFILM Healthcare Americas Corporation: Medical Device Recall in 2025 - (Recall #: Z-1407-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 11, 2025

Date Posted: March 26, 2025

Recall Number: Z-1407-2025

Event ID: 96360

Reason for Recall:

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

Status: Ongoing

Product Quantity: 104 units (69 US, 35 OUS)

Code Information:

Model numbers: Synapse PACS 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200 Software Version Numbers: Synapse PACS 7.4.000, UDI: (01)00854904006008(10)0704000; Synapse PACS 7.4.001, UDI: (01)00854904006008(10)0704001; Synapse PACS 7.4.010, UDI: (01)00854904006008(10)0704010; Synapse PACS 7.4.100, UDI: (01)00854904006008(10)0704100; Synapse PACS 7.4.110, UDI: (01)00854904006008(10)0704110; Synapse PACS 7.4.200, UDI: (01)00854904006008(10)0704200.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated