# FDA recall Z-1430-2022

> **GE Healthcare, LLC** · Class II · device recall initiated 2022-06-24.

## Product

SIGNA Premier magnetic resonance scanner, model 5748519.

## Reason for recall

Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning.  After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, MI, MN, NY, and WI.  There was government distribution but no military distribution. The countries of China, France, Hong Kong, India, Italy, Japan, Korea, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.

## Key facts

- **Recall number:** Z-1430-2022
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-06-24
- **Report date:** 2022-07-27

- **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-1430-2022

## Citation

> AI Analytics. FDA recall Z-1430-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1430-2022. Source: US FDA. Licensed CC0.

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