GE Medical Systems China Co recalls

Recall found. GE Medical Systems China Co is named in FDA Class II recall Z-2306-2026 covering MAC 5 A4 Resting ECG Analysis System 855001-001. 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. Identifying details: Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124. Status: Ongoing.

Models with recalls

MAC 5 A4 Resting ECG Analysis System 855001-001 (1)

All GE Medical Systems China Co recalls

FDA Class II · Medical device · June 10, 2026

MAC 5 A4 Resting ECG Analysis System 855001-001 recall — GE Medical Systems China Co., Ltd.

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. …

Official ID Z-2306-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.