Device Recall QRS Diagnostic Universal ECG 12 Channel ECG (IEC),

2009-42-C102636  2009-42-C102637 2009-42-C102638 2009-42-C102639 2009-42-C102640  2009-42-C102641  2009-42-C102642  2009-42-C102643  2009-42-C102644  2009-42-C102645  2009-42-C102646  2009-42-C102647  2009-42-C102648

Cardiovascular Devices

Worldwide Distribution and the countries of: Belgium, France, Italy, Mali and Senegal.

QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th Ave North, Plymouth, MN 55447 USA. || Product Usage: || The Universal ECG is an Electrocardiograph Diagnostic System designed to provide measurements and interpretative statements of a patients ECG waveform. The interpreted ECG with measurements and diagnostic statements are provided to the physician on an advisory basis only, for the physician to over read and validate or change the ECG interpretation. The ECG measurements and interpretive statements may be reviewed, edited, distributed electronically or printed. No real time monitoring or alarm capability is provided.