# FDA recall Z-1891-2018

> **Volcano Corporation** · Class II · device recall initiated 2018-03-22.

## Product

Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only.    Used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature.

## Reason for recall

The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.

## Distribution

Worldwide Distribution -- U.S., to the states of California, Connecticut, Tennessee, North Carolina, Maryland, and Oregon; and, the country of Australia.

## Key facts

- **Recall number:** Z-1891-2018
- **Recalling firm:** Volcano Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-22
- **Report date:** 2018-05-23
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rancho Cordova, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1891-2018

## Citation

> AI Analytics. FDA recall Z-1891-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1891-2018. Source: US FDA. Licensed CC0.

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