Notice names this product. FUJIFILM Healthcare Americas’s FUJIFILM Synapse PACS software v7 is named in FDA Class II recall Z-3030-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Software issue may cause the ruler measurement to be inaccurate. Identifying details: UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38. Units affected: 6 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
FUJIFILM Synapse PACS software v7
Company / brand
FUJIFILM Healthcare Americas
Lot / serial / date codes
UDI (01)00854904006008(10)0704310, Serial Numbers: CV-00272120, CV-0080080176, CV-01318490, CV-01-80102732, CV-80057523, CV-00494020-38
Distribution
Worldwide - US Nationwide distribution in the states of NY, VA, KS, OR, OH, and the country of Australia.
Agency product description and boundaries
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.