Volcano Philips IntraSight Plus
The Philips IntraSight Plus may associate image data with another patient's record, potentially causing incorrect diagnosis or treatment.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Volcano Corp recalled the Philips IntraSight Plus, REF 797423 and 797417, because the software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. The recall began on August 6, 2026, and was added to the FDA's Enforcement Report on September 25, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
- UDI-DI
- 00845225012946
- 00845225012939
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Massachusetts, Minnesota, Texas, Alabama, Georgia, California and the countries of Belgium, Denmark, Germany, Netherlands, Poland, Spain, Sweden, United Kingdom.
- Event ID
- 99730
- Recall No.
- Z-3276-2026
- Company
- Volcano CorpSan Diego, California
- Hazard
- Software defect
- Quantity recalled
- 19 systems
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report