OVERLOOKED

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Class IIOngoing

Volcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v

Recall date · record updated Oct 7, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Volcano Corp
Reason
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
Worldwide - US Nationwide distribution in the states of MA, MN, TX, AL, GA, CA and the countries of Belgium, Denmark, Germany, Netherlands, Poland, Spain, Sweden, United Kingdom.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99730…

Products

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

    Codes/lots: UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4Quantity: 19 systemsRecall no. Z-3276-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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