Class II

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

Volcano Corp · August 6, 2026

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

19 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3276-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.