| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01072-1 |
| Product Name/Description |
Q-Stress and X-Scribe Cardiac Stress Testing Systems
Q-Stress version 6 or higher
All serial numbers
Multiple product codes
X Scribe version 6 or higher
All serial numbers
Multiple product codes
ARTG 324984
(Welch Allyn Australia Pty Limited - Stress exercise monitoring system, cardiac) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
A potential change in the QRS amplitude may occur in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. The SCF is a configurable feature with multichannel recordings, which aims to reduce noise and remove inconsistent signals without distorting the ECG signal associated with stress testing.
Baxter performed internal testing using patient ECG data through the SCF algorithm, which showed an average QRS amplitude change of 5.4% reduction during pre-exercise and 7.1% reduction during peak heart rate. The maximum QRS amplitude changes observed were a 39.7% reduction during pre-exercise and a 71.0% reduction during peak heart rate.
If the QRS amplitude displayed is changed and is unrecognized by the clinician, medical intervention may be omitted, delayed, or provided that is contradictory to the patient’s true condition. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Baxter is developing a software update for Q-Stress version 6 or higher and X-Scribe version 6 or higher to resolve the issue. Baxter will contact users when the software update is available.
Until a software update becomes available and is installed, clinicians should evaluate the potential impact of the SCF as described to determine if it should be enabled or disabled during stress testing. |
| Contact Information |
1800 BAXTER (1800 229 837) - Baxter Healthcare |