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
- Hazard
- ecg-distortion
- reading-inaccuracy
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
Distribution scope not specified by the agency.
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