Reported Jun 10, 2026 · Ongoing
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
GE Medical Systems China Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems China Co., Ltd. · No. 19 Changjiang Road · Wuxi · N/A
Is this the product you have?
- MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
- Lot codes and dates
Software version 3.00 855001-001UDI-DI 00195278276070 8855002-001UDI-DI 00195278276124
- Amount recalled
- 16
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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