Qrs Diagnostic: 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.

Recall number

Z-1315-2012

Recalling firm

Qrs Diagnostic

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.

Status

Terminated

Initiated

2012-02-16

Posted

2012-03-23

Terminated

2012-08-02

Reason

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

Root 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

13 devices

Distribution

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

Lot, serial or model codes

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

510(k) numbers

["K990266"]

PMA numbers

not on file

Product code

LOS

Firm FEI

1000520092

Firm city

Maple Grove

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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