# FDA recall Z-0127-2021

> **GE Healthcare, LLC** · Class II · device recall initiated 2020-09-08.

## Product

System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.

## Reason for recall

Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA.    The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.

## Key facts

- **Recall number:** Z-0127-2021
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-08
- **Report date:** 2020-10-28
- **Termination date:** 2021-04-28

- **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-0127-2021

## Citation

> AI Analytics. FDA recall Z-0127-2021. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-0127-2021. Source: US FDA. Licensed CC0.

---

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