# FDA recall Z-0860-2022

> **GE Healthcare, LLC** · Class II · device recall initiated 2022-02-18.

## Product

1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile.  Magnetic Resonance Imaging System

## Reason for recall

There is potential for the images to be flipped left to right.

## Distribution

Worldwide Distribution.  US nationwide,  Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-0860-2022
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-18
- **Report date:** 2022-04-13

- **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-0860-2022

## Citation

> AI Analytics. FDA recall Z-0860-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0860-2022. Source: US FDA. Licensed CC0.

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