QRS Diagnostic Universal ECG 12 Channel ECG (IEC), Rx only, REF Z-7000-0400, Manufactured for QRS Diagnostic, 14755 27th

FDA device recall Z-1315-2012 · posted 2012-03-23 · Terminated

Recall details

Recalling firm

Qrs Diagnostic

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

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

LOS

Quantity affected

13 devices

Distribution

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

Date initiated

2012-02-16

Date posted

2012-03-23

Date terminated

2012-08-02

Location

Maple Grove, MN

Related 510(k) clearances