Z-1315-2012

QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic...

Name: Z-1315-2012 QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic...
Creator: Qrs Diagnostic
Published: 2012-02-16
License: https://open.fda.gov/license/

VectraCor, Inc. / initiated 2012-02-16 / Terminated / root cause: manufacturing process

FDA source

Qrs Diagnostic began a recall of 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... on 2012-02-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1315-2012
Status: Terminated
Initiated: 2012-02-16
Posted: 2012-03-23
Terminated: 2012-08-02
Recalling firm: VectraCor, Inc.
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.
Product code: LOS
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
Root cause tag: manufacturing process
FDA 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 [email protected]. For questions contact Technical Support at [email protected] or by phone 800-465-8408.
Quantity in commerce: 13 devices
Distribution: Worldwide Distribution and the countries of: Belgium, France, Italy, Mali and Senegal.
Product codes and lots: 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

Product code LOS

K990266Micromedical 12 Lead Simultaneous CableMicromedical Industries, Ltd. / cleared 1999-02-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)