FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Summary
The FDA issued a Class II for FUJIFILM Synapse PACS software v7.4.310; radiological image processing system by FUJIFILM Healthcare Americas Corporation. Reason: Software issue may cause the ruler measurement to be inaccurate..
Details
Source
Device Recall
External ID
Z-3030-2026
Action Date
2026-09-02
Status
Ongoing
Category
device
Product Description
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Lot/Code Info: UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38
Quantity Affected: 6 units
Reason for Recall
Software issue may cause the ruler measurement to be inaccurate.
Distribution
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-22
Company
Lexington, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 445 device-related FDA actions this month.
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 24 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (FUJIFILM Healthcare Americas Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FUJIFILM Healthcare Americas Corporation have FDA actions?
FUJIFILM Healthcare Americas Corporation has 36 FDA actions in our database, including 24 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3030-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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