FDAFDA · Food and drugs·Recall number Z-2306-2026
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Published June 10, 2026 · Recall initiated: April 21, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- GE Medical Systems China Co., Ltd.
- Distributor
- Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
- Lot
- Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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