Health product recall

Q-Stress and Xscribe (Version 6 or Higher)

Last updated

Summary

Product
Q-Stress and Xscribe (Version 6 or Higher)
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Q-Stress Products (Version 6 Or Higher)

All lots.

QS6-MLTCX
QS6-MXTCS
QS6-MLTC1
QS6-ATTD1
QS6-ATTDX
QS6-AXTDS
QS6-MTTC1
QS6-BLXC1
QS6-BLXCX
QS6-BXXCS
QS6-MTTCX

Q-Stress Software

All lots.

QSERV-6AA-XXXXA
QR-6AC-AXXXX

XScribe Products (Version 6 Or Higher)

All lots.

XSERV-6AA-XXXXA
XSCRIBE-6AA-AFAAC
XSCRIBE-6AA-AFAAA

Issue

Baxter Corporation is issuing an urgent medical device correction for the Q-Stress and XScribe cardiac stress testing systems (Q-Stress version 6 or higher and XScribe version 6 or higher) due to a potential change in the QRS amplitude identified in electrocardiogram (ECG) readings when the source consistency filter (SCF) is enabled.

Recall Start Date: December 3, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Welch Allyn, Inc.

4341 State Street Road, Skaneateles Falls, New York, United States, 13153

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74778

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