Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v recall (Volcano Corp)
Medical deviceClass IIOngoing
Summary: Volcano Corp is recalling Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA. Reason: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
What is being recalled
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Why
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alabama, California, Georgia, Massachusetts, Minnesota, Texas)
How to tell if yours is affected
UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3276-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 6, 2026 |
| Reported | October 7, 2026 |
| Company | Volcano Corp |
| Company location | San Diego, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 19 systems |
More recalls from Volcano Corp · all medical device recalls · recalls from August 2026