Day

June 3, 2026
03
Jun

FDA Recall: Software inadvertently made available for customer use

June 3, 2026
Company: GE Medical Systems China Co., Ltd. Date of Enforcement Report: 6/3/2026 Class: II PRODUCT: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph Recall Number: Z-2306-2026 REASON: Software in development inadvertently made available for customer use. Use of this software version can result in clinical information...
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