Reported Sep 2, 2026 · Ongoing · Updated Sep 16, 2026

FUJIFILM Synapse PACS software v7.4.310; radiological image processing system

FUJIFILM Healthcare Americas Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: FUJIFILM Healthcare Americas Corporation · 81 Hartwell Ave Ste 300 · Lexington, MA · 02421-3160

Is this the product you have?

  • FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Lot codes and dates
  • UDI (01)00854904006008(10)0704310
  • Serial Numbers
    • CV-00272120
    • CV-0080080176
    • CV-01318490
    • CV-01-80102732
    • CV-80057523
    • CV-00494020-38
Amount recalled
6 units

Where it was sold

Why it was recalled

Software issue may cause the ruler measurement to be inaccurate.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (Enforcement Report)

Read the FDA (weekly enforcement report) notice

Data as of Sep 19, 5:49 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.