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 device recall Z-1407-2025 · posted 2025-03-20 · Open, Classified

Recall details

Recalling firm

FUJIFILM Healthcare Americas Corporation

Reason for recall

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

Action taken

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 appropriate actions when rendering a diagnosis for patients under 18 years of age. The following workarounds can be used: 1) The image acquisition date and date of birth are displayed on the Image. The end-user can use the dates to verify the age or, 2) Open the Series Viewer by double clicking on the thumbnail displayed on top the Synapse VX Image viewing window or the worklist. The Series Viewer Window will render the image on the server using the Server-side rendering (Zero Viewer component) which will calculate the age correctly. Alternatively, the user can switch to the Synapse PACS Zero Viewer/Thin Viewer (Server-side Rendering). The Synapse PACS Zero Viewer/Thin Viewer calculates the age correctly. ACTIONS TO BE TAKEN BY THE CUSTOMER/END-USER 1) Please complete and return the Field Action Verification Form attached to this communication. Responding with the information requested is essential for ensuring appropriate action is taken. 2) Please contact Customer Service at 1-888-FUJIMED (1-888-385-4633) to schedule a patch update. Fujifilm regrets any inconvenience this action may cause and appreciates your understanding and cooperation. Please contact our field action coordinator, Jay Wigley, via email at hcusquality@fujifilm.com, if you have any further questions regarding this field action. Please contact Technical Assistance Center (TAC) at 1-888-385-4622 or 1-888-FU

Root cause

Software change control

Status

Open, Classified

Product code

LLZ

Quantity affected

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,

Date initiated

2025-02-11

Date posted

2025-03-20

Location

Lexington, MA

Related 510(k) clearances