Ge Medical Systems China Co., Ltd. No. 19 Changjiang Road Development Zone National Hi-tech Xin District Wuxi China: Transmitters And Receivers, Electrocardiograph, Telephone
Recall Summary GE Medical Systems is recalling MAC 5 A4 and MAC 5 A5 electrocardiograph (ECG) systems because a development software version was accidentally released for clinical use. This software can incorrectly link patient heart test results to the wrong patient, which could affect medical decisions. The devices were distributed nationwide in the U.S., as well as in India, Italy, South Korea, and the United Kingdom.
- Recalling firm
- GE Medical Systems China Co., Ltd. No. 19 Changjiang Road Development Zone National Hi-Tech Xin District Wuxi China
- Product
- MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/36d358f4-c538-4a98-b844-0821acd22984