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Medical Device Recall: Baxter Healthcare/Welch Allyn/Mortara Xscribe and Q-Stress Cardiac Stress Testing Systems Version 6
Medical Device Recall: Baxter Healthcare/Welch Allyn/Mortara Xscribe and Q-Stress Cardiac Stress Testing Systems Version 6
Introduction:
Baxter Healthcare, a leading manufacturer of ECG Stress Testing Systems, has issued Class 2 medical device corrections for the following Systems under the brand names Baxter Healthcare, Welch Allyn, and Mortara:
– Q-Stress Cardiac Stress Testing System, Version 6
– Xscribe Cardiac Stress Testing System, Version 6
– Xscribe CP Cardiac Stress Testing System, Version 6
FDA Recall Links:
Z-0705-2024 – Q-Stress
Z-0706-2024 – Xscribe
Z-0707-2024 – Xscribe CP
Recall Scope:
For Q-Stress Systems: Over 140 Models, All Serial Numbers.
For Xscribe Systems: Over 70 Models, All Serial Numbers.
For Xscribe CP Systems: 7 Models, All Serial Numbers.
Introduction:
Baxter Healthcare, a leading manufacturer of ECG Stress Testing Systems, has issued Class 2 medical device corrections for the following Systems under the brand names Baxter Healthcare, Welch Allyn, and Mortara:
– Q-Stress Cardiac Stress Testing System, Version 6
– Xscribe Cardiac Stress Testing System, Version 6
– Xscribe CP Cardiac Stress Testing System, Version 6
FDA Recall Links:
Z-0705-2024 – Q-Stress
Z-0706-2024 – Xscribe (Note: at the time of posting, this Recall has incorrect/incomplete serial number data)
Z-0707-2024 – Xscribe CP
Recall Scope:
For Q-Stress Systems: Over 140 Models, All Serial Numbers.
For Xscribe Systems: Over 70 Models, All Serial Numbers.
For Xscribe CP Systems: 7 Models, All Serial Numbers.
Reason for Recall:
Baxter Healthcare has stated that a potential distortion identified in electrocardiogram (ECG) readings were identified when the Source Consistency Filter (SCF) was enabled.
Due to the potential impact on the QRS complex, Baxter is developing a software update for QStress version 6 or higher and XScribe version 6 or higher to resolve the issue.
FDA’s Determination:
The FDA has identified the software design as the cause of the recall.
Recall Quantity:
The recall affects 9,347 total units.
Recall Actions:
The following actions are listed in the Recall:
– Clinicians should evaluate the potential impact of the SCF as described to determine if it should be enabled or disabled during stress testing and provided the method for disabling the setting.
– If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them, informing them of the requirement to evaluate the potential impact of the SCF during stress testing. – Respond using the customer portal: https://BaxterFieldActionCustomerPortal.onprocess.com.
– If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures and check the associated box on the customer portal.
– If you purchased this product from a distributor, please note that the Baxter reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to your distributor/wholesaler according to their instructions.
Contact Information:
For general questions regarding this communication, contact Baxter (legacy Welch Allyn and Hillrom) Customer Service at 800-535-6663, Option 1, or Option 2 for Technical Support, between the hours of 8:00 am and 8:00 pm Eastern Time, Monday through Friday.
Recall Support Documents:
