Recall Z-3276-2026 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Volcano Corp
Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA
| Date | Sep 25, 2026 (initiated Aug 6, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On August 6, 2026, Philips issued a Urgent Medical Device Correction to affected consignees. Philips ask consignees to take the following actions: 1. Contact your local Philips Service representative in advance of any changes to the worklist provider, Azurion software, interface configuration, or hospital IT environment, as such changes may affect the Study ID field. Your Philips Service representative will help evaluate any impact and/or reverify as applicable. Otherwise, you may continue to use the device in accordance with the intended use. 2. Please circulate this notice to all users of t |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K253714 | IntraSight Plus Philips Image Guided Therapy Corporation, Feb 24, 2026 |