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.

QRS Diagnostic has initiated a recall involving Universal ECG 12 Lead IEC ECG Devices. 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 interpretatio

QRS Diagnostic sent an Urgent Medical Device Recall letter dated February 9, 2012 via e-mail and mail to all affected consignees. The letter identified the affected product, description of the problem, and actions to be taken. If the affected product have been further distributed, consignees are instructed to notify them at once of the product recall. Consignees were instructed to contact Uni-com immediately for a replacement device. Uni-com will provide this replacement at no charge and will arrange to have the device returned to QRS Diagnostic for correction. Additionally, consignees were instructed to complete the attached Medical Device Correction Receipt Confirmation Form and return to QRS Diagnostic via fax at country code =1-763-559-2961 or email [email protected]. For questions contact Technical Support at [email protected] or by phone 800-465-8408.