Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Summary
The FDA issued a Class II for Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 by Volcano Corp. Reason: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment..
Details
Source
Device Recall
External ID
Z-3276-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
Lot/Code Info: UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
Quantity Affected: 19 systems
Reason for Recall
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-06
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Volcano Corp has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Volcano Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Volcano Corp have FDA actions?
Volcano Corp has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3276-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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