Philips IntraSight Plus Recall: Software Issue
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Philips IntraSight Plus recalled?
Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
- Agency record number
- Z-3276-2026
- Product
- Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
- Recalling firm
- Volcano Corp
- 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.
- Recall started
- August 6, 2026
- Report date
- October 7, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)