# Class II recall Z-3276-2026: Volcano Corp

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3276-2026 |
| Recalling firm | Volcano Corp |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| 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 initiated | 2026-08-06 |
| Reported | 2026-10-07 |
| Firm location | San Diego, CA, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3276-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.