FDAClass IISeptember 2, 2026

FUJIFILM Synapse PACS software v7.4.310 recall: Software Issue

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

Why was FUJIFILM Synapse PACS software v7.4.310 recalled?

Software issue may cause the ruler measurement to be inaccurate.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38

Product
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Recalling firm
FUJIFILM Healthcare Americas Corporation
Quantity
6 units
Distribution
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Recall date
September 2, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls