Company:QRS Diagnostic.
Date of Enforcement Report 4/4/12
Class ll:
PRODUCT
QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400. 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. Recall # Z-1315-2012
REASON
This recall has been initiated because the chest lead wires on these devices may have been improperly labeled. Incorrect labeling of the lead wires could result in improper lead wire placement on the patient which may result in inaccurate waveforms being displayed to the user and an inaccurate interpretation by the Office Medic Software.
RECALLING FIRM/MANUFACTURER
QRS Diagnostic, Maple Grove, MN, by letter dated February 9, 2012. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
13 devices
DISTRIBUTION
Nationwide and Belgium, France, Italy, Mali and Senegal
