# FDA recall Z-0134-2022

> **GE Healthcare, LLC** · Class II · device recall initiated 2021-08-26.

## Product

SIGNA Pioneer  nuclear magnetic resonance imaging system

## Reason for recall

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.

## Distribution

Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico    OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK

## Key facts

- **Recall number:** Z-0134-2022
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-26
- **Report date:** 2021-10-27
- **Termination date:** 2026-05-04

- **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-0134-2022

## Citation

> AI Analytics. FDA recall Z-0134-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0134-2022. Source: US FDA. Licensed CC0.

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