# FDA recall Z-0901-2022

> **Volcano Corp** · Class III · device recall initiated 2022-01-24.

## Product

IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102

## Reason for recall

Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.

## Distribution

US: CO, GA, MA, TX, AZ, NY, PA, CA, FL, MO, OR, MD, NC, TN    OUS: JP, DE, GB, NL, IT

## Key facts

- **Recall number:** Z-0901-2022
- **Recalling firm:** Volcano Corp
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-24
- **Report date:** 2022-04-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0901-2022

## Citation

> AI Analytics. FDA recall Z-0901-2022. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0901-2022. Source: US FDA. Licensed CC0.

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