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FUJIFILM Healthcare Americas Corporation: FUJIFILM Synapse PACS software v7.4.310; radiological image processing system

Medical DevicesSource: FDA (device) · Date: 2026-09-02

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
FUJIFILM Healthcare Americas Corporation
Product
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Reason / hazard
Software issue may cause the ruler measurement to be inaccurate.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Recall initiated
2026-07-22
Code info
UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38
Product quantity
6 units
Voluntary mandated
Voluntary: Firm initiated
City
Lexington
State
MA
Country
United States
Event id
99529
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