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 being associated with the incorrect patient. This could impact clinical decision-making.

RECALLING FIRM/MANUFACTURER:

GE Medical Systems China Co., Ltd.

VOLUME:

16

DISTRIBUTION:

Worldwide – US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.