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FDA · Medical device recall

Synapse PACS Software Version 7.4.x…

Recall started · FDA enforcement report March 26, 2025 Class II

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

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Enforcement report date
March 26, 2025
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
Filed by
FUJIFILM Healthcare Americas Corporation
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.
Reason
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
Quantity
104 units (69 US, 35 OUS)
Codes and lots
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.
Recall started
Feb. 11, 2025
Voluntary or mandated
Voluntary: Firm initiated
Device type
System, Image Processing, Radiological
Root cause (FDA)
Software change control
What the company told customers
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
Recall number
Z-1407-2025

What the record says about this device

A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.

Four steps: a device or a product, the reason the record gives, the record's wordsA simplified drawing for a device record; the mark follows the reason the record gives, not a photograph of the product. Left, for comparison: the same drawing without what the record names. Right: this record.1 The product: Synapse PACS Software Version 7.4.x…2 The record describes an image or a value that is wrong3 What the record says4 What the record listsFOR COMPARISONthe same drawing, withoutwhat the record namesTHIS RECORDwhat the record names,step by stepincorrect computed

“The incorrect computed patient age is showing in VX for patients less than 3 months old.”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 enforcement report, 2025-03-26. The caption is the record's own words.

A generic device, not the product. The mark follows the record's own words.

If the drawing and the record's words differ, the words govern. A drawing is chosen by rules and an AI reading of the record and can miss what it means; report one with the form below.

FDA device name: System, Image Processing, Radiological

Distributed in (FDA's record): Arizona Arkansas California Colorado Connecticut Florida Georgia Hawaii Illinois Indiana Kansas Kentucky Louisiana Massachusetts Minnesota Mississippi Missouri New Jersey New York North Carolina Ohio Oklahoma Oregon Tennessee Texas Vermont Washington West Virginia Wisconsin Wyoming

This recall among the others

  • FDA's enforcement report came 43 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
  • FUJIFILM Healthcare Americas: 7 other recalls or notices on this site in the three years before this one (from March 27, 2022).

Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.

What should I do? How serious is a recall? Classes and warnings explained · How to read this record

Source: FDA · Medical device enforcement report, recall number Z-1407-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.

Cite this record
FDA recall record Z-1407-2025, March 26, 2025. "Synapse PACS Software Version 7.4.x." PlainRecords, https://plainrecords.com/recall/device/z-1407-2025/ (as of the day it was built).

At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections

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