Recall Z-3276-2026— Volcano Corp

Name: FDA recall Z-3276-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-06

Class II · Ongoing

Class II FDA medical device recall by Volcano Corp, initiated 2026-08-06. It names one FDA 510(k) clearance: K253714. Product: Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA. Reason: Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment..

Recalling firm: Volcano Corp
Classification: Class II
Status: Ongoing
Initiated: 2026-08-06
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K253714 — IntraSight PlusPhilips Image Guided Therapy Corporation·cleared 2026-02-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ, 1000 VA

Reason for recall

Software system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment.

Data sourced from openFDA. This site is unofficial and independent of the FDA.