Recall Z-1407-2025 ยท LLZ System, Image Processing, Radiological
FUJIFILM Healthcare Americas Corporation
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.
| Date | Mar 20, 2025 (initiated Feb 11, 2025) |
| Status | Open, Classified |
| Reason | The incorrect computed patient age is showing in VX for patients less than 3 months old. |
| Root cause | Software change control |
| Action | On February 11, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. ACTIONS TO BE TAKEN BY THE COMPANY Fujifilm will issue corrections for all impacted 7.4.x versions. The following patch releases will be made available: - 7.4.020 for 7.4.0x versions (immediately available) - 7.4.120 for 7.4.1x versions (available February 28, 2025) - 7.4.210 for 7.4.2x versions (available February 28,2025) ACTIONS THAT CAN BE TAKEN BY THE END-USER IMMEDIATELY Regarding this issue, Synapse PACS VX can safely be used by the end-user as long as; 1] the end-user is aware of the issue and, 2] takes |
| Quantity | 104 units (69 US, 35 OUS) |
| 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 |
| FDA record | Open on fda.gov |