FUJIFILM Synapse PACS Software v7.4.310 Recall Over Inaccurate Ruler Measurements

Source: FDA · United States and Australia

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

FUJIFILM Healthcare Americas Corporation is recalling six units of its Synapse PACS software due to a software issue that may cause inaccurate ruler measurements.

The full picture behind this FDA recall

This notice was issued by FDA on September 10, 2026 and geographically references United States and Australia. The FDA classifies this as a Class II recall, with the stated reason "Software issue may cause the ruler measurement to be inaccurate.", distributed worldwide - us nationwide distribution in the states of ny, va, ks, or, oh, and the country of australia.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, Devices.

What Happened

FUJIFILM Healthcare Americas Corporation is recalling its FUJIFILM Synapse PACS software v7.4.310 because a software issue may cause the ruler measurement to be inaccurate.

Which Products Are Affected

The recall affects FUJIFILM Synapse PACS software v7.4.310, a radiological image processing system. Six units are affected with UDI (01)00854904006008(10)0704310 and serial numbers CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, and CV-00494020-38. Distribution occurred in the states of NY, VA, KS, OR, OH, and Australia. The recall number is Z-3030-2026.

What You Should Do

Consumers should contact FUJIFILM Healthcare Americas Corporation for further instructions regarding the recalled software.

Why This Matters

The software issue affects radiological image measurements in a Class II recall involving six units distributed in multiple states and Australia.

Source

FDA recall number Z-3030-2026

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two cross-category peer sets, both computed from Areazine's own archive: notices with a similar body length, and notices near the same severity and agency date. These are drawn from other categories, not the same-feed Related list above.

What People Ask

Common questions about this FDA recall.

What is this FDA recall about?
FUJIFILM Healthcare Americas Corporation is recalling six units of its Synapse PACS software due to a software issue that may cause inaccurate ruler measurements.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How is this recall classified, and why does that matter?
The FDA classifies this as a Class II recall, citing "Software issue may cause the ruler measurement to be inaccurate." as the reason. Class I is the most serious (reasonable probability of serious harm), Class II is a moderate or temporary health risk, and Class III is unlikely to cause harm.
What area is affected?
This alert affects United States and Australia. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.