# FDA recall Z-0306-2021

> **GE Healthcare, LLC** · Class II · device recall initiated 2020-09-21.

## Product

Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

## Reason for recall

There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of FL, GA, IL, MI, NC, NE, NJ, PA, TX, VA, WA, and WI. The countries of Australia, Austria, Belgium, Canada, China, Denmark, Estonia, Finland, France, Japan, Kuwait, Norway, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

## Key facts

- **Recall number:** Z-0306-2021
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-21
- **Report date:** 2020-11-04
- **Termination date:** 2022-12-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0306-2021

## Citation

> AI Analytics. FDA recall Z-0306-2021. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0306-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*