Recalling firm
GE Medical Systems China Co., Ltd.
Product type
Device
Status
Ongoing
Report date
2026-06-10
Distribution
Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
Product quantity
16
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Data IntegrityReason for recall
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.
Product description
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Code / lot info
Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
Other recalls SPEQ maps to Data Integrity
See all Data Integrity recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.