- Recalling firm
- Volcano Corp
- Reason for recall
- Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
- Affected products (lot / model / serial)
- UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
- Units affected
- 19 systems
- Distribution pattern
- 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.
- Firm location
- San Diego, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3276-2026
- Recall initiated
- August 6, 2026
- FDA classification date
- September 25, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99730
- Last updated on HTM Vibe
- October 13, 2026
