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

Class II
Recalling firm
FUJIFILM Healthcare Americas Corporation
Reason for recall
Software issue may cause the ruler measurement to be inaccurate.
Affected products (lot / model / serial)
UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38
Units affected
6 units
Distribution pattern
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Firm location
Lexington, MA, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Letter
Product type
Devices
Status
Ongoing
Recall number
Z-3030-2026
Recall initiated
July 22, 2026
FDA classification date
August 26, 2026
FDA report date
September 2, 2026
FDA event ID
99529
Last updated on HTM Vibe
September 8, 2026
View on openFDA