Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Published October 7, 2026 · Recall initiated: August 6, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Volcano Corp
- Distributor
- 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.
- Lot
- UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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Questions about this recall
Was Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA recalled?
Yes. FDA published recall Z-3276-2026 on October 7, 2026. Reported hazard: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
What should I do if I have this product?
Voluntary: Firm initiated · Letter
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