MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Class II
- Recalling firm
- GE Medical Systems China Co., Ltd.
- 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 pattern
- Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
- Status
- Ongoing
- Recall number
- Z-2306-2026
- Recall initiated
- April 21, 2026
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