Q-Stress and Xscribe (Version 6 or Higher)
Brand(s)
Last updated
Summary
Product
Q-Stress and Xscribe (Version 6 or Higher)
Issue
Medical devices - Performance
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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