fda_recall · device_recall · high
GE Medical Systems China Co., Ltd. — Class II recall: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis…
- Event date
- 2026-06-10 00:00:00Z
- Observed
- 2026-07-09 22:52:19Z
- Source ID
- Z-2306-2026
- Payload hash
- 8cb1c8939077777ec7a58a49…
Summary
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. Status: Ongoing.
Informational only. Not legal, financial, or medical advice.