Volcano Corp recalls Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v
- Recalling company
- Volcano Corp
- Product
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 6, 2026
- Reported
- Oct 7, 2026
- Distribution
- 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.
- Status
- Ongoing
- Quantity
- 19 systems
- Lot / codes
- UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
- Company location
- San Diego, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3276-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3276-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.