GE Medical Systems China Co., Ltd. recalls MAC 5 A4 Resting ECG Analysis System 855001-001
- Recalling company
- GE Medical Systems China Co., Ltd.
- Product
- MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 21, 2026
- Reported
- Jun 10, 2026
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
- Status
- Ongoing
- Quantity
- 16
- Lot / codes
- Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
- Company location
- Wuxi
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2306-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2306-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.