Company: Volcano Corp
Date of Enforcement Report: 9/25/2026
Class: II
PRODUCT
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Recall Number:
Z-3276-2026
REASON:
Software system may associate image data from one patient with another patient’s record, potentially resulting in incorrect diagnosis or treatment.
RECALLING FIRM/MANUFACTURER:
Volcano Corp
VOLUME:
19 systems
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.
