FDAClass II · Medical device · Recall Z-3030-2026 · Recalled September 2, 2026

FUJIFILM Synapse PACS software v7 recall — FUJIFILM Healthcare Americas Corporation

Agency report date: September 2, 2026.

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.

2. Agency hazard and consumer action

FDA reports: Software issue may cause the ruler measurement to be inaccurate.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: FUJIFILM Synapse PACS software v7 recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3030-2026
Brand: All FUJIFILM Healthcare Americas recalls
Classification: Class II
Units affected: 6 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

FUJIFILM Synapse PACS software v7 recall status

Companies & origin

Recalling firm location: Lexington, MA, United States
Firm address: 81 Hartwell Ave Ste 300, N/A, 02421-3160

Identifying details (verbatim from the notice)

Product codes / lots: 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.
Firm notified the public via: Letter
FDA event ID: 99529
Recall initiated: July 22, 2026
FDA classified: August 26, 2026
FDA report date: September 2, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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