Reported Oct 7, 2026 · Ongoing · Updated Oct 13, 2026
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Volcano Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Volcano Corp · 3721 Valley Centre Dr Ste 500 · San Diego, CA · 92130-3328
Is this the product you have?
- Philips IntraSight Plus REF
797423 and 797417 100-120v-220-240v50/60hZ1000 VA
- Lot codes and dates
- UDIREF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
- Amount recalled
- 19 systems
Where it was sold
Why it was recalled
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
This product could cause temporary or reversible health problems — stop using it.
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