Class 2 Device Recall QRS Diagnostic Universal ECG 12 Channel ECG (IEC),

• Date Initiated by Firm: February 16, 2012
• Date Posted: March 23, 2012
• Recall Status: Terminated on August 02, 2012
• Recall Number: Z-1315-2012
• Recall Event ID: 61282
• 510(K)Number: K990266
• Product Classification: System, ecg analysis - Product Code LOS
• Product: 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Qrs Diagnostic; 6901 E Fish Lake Rd Ste 188; Maple Grove MN 55369-5457
• For Additional Information Contact: 763-559-8560
• Manufacturer Reason for Recall: 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
• FDA Determined Cause: Process control
• Action: 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 support@QRSDiagnostic.com. For questions contact Technical Support at support@QRSDiagnostic.com or by phone 800-465-8408.
• Quantity in Commerce: 13 devices
• Distribution: Worldwide Distribution and the countries of: Belgium, France, Italy, Mali and Senegal.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LOS and Original Applicant = MICROMEDICAL INDUSTRIES, LTD.