High FDA (Devices)·Z-0705-2024·Announced 2024-01-17

Cardiac Stress Testing System may produce distorted electrocardiogram readings

The Q-Stress Cardiac Stress Testing System version 6 may distort electrocardiogram (ECG) readings when the Source Consistency Filter is enabled. Healthcare facilities should verify ECG readings and consult product documentation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a cardiac diagnostic device where ECG reading distortion has been identified as a potential hazard. Although no illnesses or injuries have been reported, the risk of harm is significant in a cardiac testing context, as distorted readings could affect patient diagnosis and treatment decisions. This meets the High severity criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The FDA is recalling the Q-Stress Cardiac Stress Testing System, version 6, manufactured by Baxter Healthcare Corporation. The system is used to conduct cardiac stress tests and may produce distorted electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) feature is enabled.

Approximately 4,687 units have been distributed across the United States and multiple countries including Canada, Australia, and various nations in Europe, Asia, Africa, and Latin America. Distortion in ECG readings could affect the interpretation of cardiac test results and potentially impact clinical decision-making for patients undergoing stress testing.

Healthcare facilities, clinicians, and patients using affected units should review the recall notice and product documentation. If the Source Consistency Filter is used, verify the accuracy of any ECG readings obtained. Contact Baxter Healthcare Corporation for detailed guidance on proper device use and any necessary actions.

The recalled product

Product: Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — Cardiac Testing Equipment
Hazard: ecg-distortion
reading-inaccuracy
Affected units: 4,687

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

a) QS6-BXXCS
UDI/DI 00732094263176
Serial Numbers: 116350524925
116490541255
b) QS-6CC-DGCXX
UDI/DI 00732094308716
Serial Numbers: 119050000134
c) QS-6CC-DFCXX
UDI/DI 00732094308723
Serial Numbers: 122290000606
122230001869
122230001868
122150001605
122150001604
122090000843
119310001134
119240000440
122430000522
122430000523
119050000135

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · ecg distortion