Class IIDeviceOngoing

Volcano Corp

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

Reason for recall

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

Details

Recall number: Z-3276-2026
Event ID: 99730
Recall initiated: Aug 6, 2026
Classified: Sep 25, 2026
Reported: Oct 7, 2026
Quantity: 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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: San Diego, CA, United States
Lot / code info: UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4