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Q-stress and xscribe (version 6 or higher)

Official notice

21 Dec 2023

Last checked

21 Dec 2023

Medium riskHealth Canada

An official Health Canada notice concerns Q-stress and xscribe (version 6 or higher). 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 Published 2023-12-21.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74778

Official notice

2023-12-21

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74778

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Affected products

Product 1

Affected products - Q-Stress Software, Lot or serial number - All lots., Model or catalog number - QSERV-6AA-XXXXA QR-6AC-AXXXX

Product 2

Affected products - XScribe Products (Version 6 Or Higher), Lot or serial number - All lots., Model or catalog number - XSERV-6AA-XXXXA XSCRIBE-6AA-AFAAC XSCRIBE-6AA-AFAAA

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Welch Allyn, Q-stress And Xscribe.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74778

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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