Official recall notice

FDA DeviceClass IINotable

Philips IntraSight Plus Recall (Oct 2026) – Volcano

Product: Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA

Recall date
2026-10-07
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4

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