Z-1407-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2025
- Initiation Date
- February 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104 units (69 US, 35 OUS)
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.
Reason for Recall
The incorrect computed patient age is showing in VX for patients less than 3 months old.
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
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.