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.

Code information: Software version 3.00 855001-001, UDI-DI 00195278276070 8855002-001, UDI-DI 00195278276124

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