CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Fujifilm Synapse Pacs recalled by FUJIFILM Healthcare Americas

FUJIFILM Healthcare Americas is recalling Fujifilm Synapse Pacs, distributed nationwide in the US. The recall was initiated on 22 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38

Quantity recalled6 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3030-2026
FDA event ID: 99529
Recalling firm: FUJIFILM Healthcare Americas, Lexington, MA
Classification: Class II
Status: Ongoing
Recall initiated: 22 Jul 2026
FDA classified: 26 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Medical Software

Timeline

22 Jul 2026	Recall initiated by company
26 Aug 2026	Classified by FDA	+35 days
2 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software issue may cause the ruler measurement to be inaccurate.

Product as listed by the FDA

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

Where it was distributed

Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.

Nationwide Kansas New York Ohio Oregon Virginia

Questions about this recall

Is Fujifilm Synapse Pacs recalled?

Yes. FUJIFILM Healthcare Americas recalled Fujifilm Synapse Pacs on 22 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-3030-2026.

Why was it recalled?

Software issue may cause the ruler measurement to be inaccurate.

Which lots are affected?

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

Where was it sold?

Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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11 Feb 2026Device	CLASS II	FDR Visionary Suite recalled by FUJIFILM Healthcare Americas	FUJIFILM Healthcare Americas	Other	Nationwide
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