Is Volcano Corp recalled?

Yes — a recall has been published. Reason: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

TemporaryFDAOngoing

Can cause harm that is usually temporary.

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

Check the device or its packaging for

UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4

Why: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
Distributed: 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.
Company: Volcano Corp
Announced: 7 October 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 6 August 2026

Source: FDA record Z-3276-2026 · retrieved 25 September 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.