FDA Medical devices recall ·
Synapse PACS Software Version 7.4.x recall
- Recall number
- Z-1407-2025
- Date
- (initiated February 11, 2025)
- Company / brand
- FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300, Lexington, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 104 units (69 US, 35 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
The incorrect computed patient age is showing in VX for patients less than 3 months old.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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: 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
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1407-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.