FDAFDA recall Z-3276-2026 · Oct 7, 2026
Volcano Corp: Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v recall
Recall found
Product
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Reason for recall
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
- Quantity
- 19 systems
- 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.
- Recalling firm
- Volcano Corp, San Diego, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-06
Source: openFDA enforcement record Z-3276-2026 · search recall number Z-3276-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.