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Class IIOngoing

FUJIFILM Healthcare Americas Corporation recalls FUJIFILM Synapse PACS software v7

Recall date · record updated Sep 2, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
FUJIFILM Healthcare Americas Corporation
Reason
Software issue may cause the ruler measurement to be inaccurate.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99529…

Products

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

    Codes/lots: UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38Quantity: 6 unitsRecall no. Z-3030-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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