FDAFDA · Food and drugs·Recall number Z-3030-2026
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Published September 2, 2026 · Recall initiated: July 22, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software issue may cause the ruler measurement to be inaccurate.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- FUJIFILM Healthcare Americas Corporation
- Distributor
- Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
- Lot
- UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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