Notice names this product. Volcano’s Philips IntraSight Plus REF is named in FDA Class II recall Z-3276-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. Identifying details: UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4. Units affected: 19 systems. Status: Ongoing.
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.
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
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.
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
Company / brand: Volcano recalls
Affected product: Philips IntraSight Plus REF recall status
Official ID Z-3276-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.