FDAHealthApril 21, 2026

GE Medical Systems China Co., Ltd. — MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph

⚠️ 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.

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 21, 2026

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

What's affected?

Product: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Brand: GE Medical Systems China Co., Ltd.
Lot code: Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124

Additional details

Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 16.

View original FDA notice →

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