Class IIDeviceOngoing

FUJIFILM Healthcare Americas Corporation

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

Reason for recall

Software issue may cause the ruler measurement to be inaccurate.

Details

Recall number: Z-3030-2026
Event ID: 99529
Recall initiated: Jul 22, 2026
Classified: Aug 26, 2026
Reported: Sep 2, 2026
Quantity: 6 units
Distribution: Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Lexington, MA, United States
Lot / code info: UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38