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FDA · Medical devices ·

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

FUJIFILM Healthcare Americas Corporation recalled FUJIFILM Synapse PACS software v7.4.310; radiological image processing system on September 2, 2026 because of software issue may cause the ruler measurement to be inaccurate. It was sold nationwide.

Why it was recalled

Software issue may cause the ruler measurement to be inaccurate.

What's recalled

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

Quantity: 6 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
FUJIFILM Healthcare Americas Corporation, Lexington, MA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Status
Ongoing
Recall number
Z-3030-2026
Source
U.S. Food and Drug Administration

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