# FDA recall Z-2133-2025

> **GE Medical Systems, LLC** · Class II · device recall initiated 2025-05-23.

## Product

SIGNA PET/MR

## Reason for recall

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

## Distribution

Worldwide distribution - US Nationwide and the country of China.

## Key facts

- **Recall number:** Z-2133-2025
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-23
- **Report date:** 2025-07-30

- **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-2133-2025

## Citation

> AI Analytics. FDA recall Z-2133-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2133-2025. Source: US FDA. Licensed CC0.

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