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

Medical DevicesSource: FDA (device) · Date: 2026-10-07

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Volcano Corp
Product
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Reason / hazard
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-08-06
Code info
UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
Product quantity
19 systems
Voluntary mandated
Voluntary: Firm initiated
City
San Diego
State
CA
Country
United States
Event id
99730
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