# FDA recall Z-0131-2021

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

## Product

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

## 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-0131-2021
- **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-0131-2021

## Citation

> AI Analytics. FDA recall Z-0131-2021. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0131-2021. Source: US FDA. Licensed CC0.

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