# FDA recall Z-2306-2026

> **GE Medical Systems China Co., Ltd.** · Class II · device recall initiated 2026-04-21.

## Product

MAC 5 A4 Resting ECG Analysis System 855001-001;  MAC 5 A5 Resting ECG Analysis System 8855002-001.  Electrocardiograph

## Reason for recall

Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making.

## Distribution

Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.

## Key facts

- **Recall number:** Z-2306-2026
- **Recalling firm:** GE Medical Systems China Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-21
- **Report date:** 2026-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wuxi, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2306-2026

## Citation

> MORVS. FDA recall Z-2306-2026. Retrieved 2026-10-18 from https://api.morvs.ai/recall/Z-2306-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*