United StatesMAC 5 A4 Resting ECG Analysis System (855001-001, software version 3.00, UDI-DI 00195278276070) and MAC 5 A5 Resting ECG Analysis System (8855002-001, UDI-DI 00195278276124) electrocardiographs are affected. A software-in-development was inadvertently made available for customer use, which can result in clinical information being associated with the incorrect patient and could impact clinical decision-making.
What's being recalled
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Recalling firm: GE Medical Systems China Co., Ltd., Wuxi, China.
How to identify it
Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)