Device recall
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
- Recall number
- Z-3276-2026
- Event id
- 99730
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Volcano Corp
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 6, 2026
- Center classification date
- Sep 25, 2026
- Product code
- IYO
- Device type
- System, Imaging, Pulsed Echo, Ultrasonic
- Reason
- Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.
- Root cause
- Software Design Change
- Quantity
- 19 systems
- Code info
- UDI: REF: 797423:(01)00845225012946/REF:797417: (01)00845225012939 all Philips IntraSight Plus Systems with Software Version 6.0.4
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K253714
- Location
- San Diego, CA, United States