Volcano recalls

Recall found. Volcano is named in FDA Class II recall Z-3276-2026 covering Philips IntraSight Plus REF. 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. Status: Ongoing.

Models with recalls

Philips IntraSight Plus REF (1)

All Volcano recalls

FDA Class II · Medical device · October 7, 2026

Philips IntraSight Plus REF recall — Volcano Corp

Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

Official ID Z-3276-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 12:00 PM UTC.