XScribe Cardiac Stress Testing System may distort ECG readings
Baxter Healthcare Corporation is recalling 2,985 units of the XScribe Cardiac Stress Testing System, version 6, due to potential distortion in electrocardiogram readings when the Source Consistency Filter is enabled. No injuries have been reported.
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 for potential distortion in ECG readings affecting diagnostic accuracy in cardiac stress testing. No illnesses or injuries have been reported, and the hazard is theoretical, which per the rubric caps severity at High for risk-of-harm products where injury has not been reported.
Plain-English summary
Baxter Healthcare Corporation is recalling 2,985 units of the XScribe Cardiac Stress Testing System, version 6, due to a potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. This system is used to conduct cardiac stress testing and monitor heart function.
The affected units were distributed to the United States (including Puerto Rico), Canada, Australia, and numerous countries throughout Asia, Europe, the Middle East, Africa, and Latin America. Specific serial numbers for affected units are documented in the FDA recall notice.
The potential distortion in ECG readings could affect the accuracy of cardiac test results. No injuries or illnesses related to this defect have been reported to the FDA.
The recalled product
- Product
- XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6
- 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)
- Product Code
- UDI/DI Number
- Serial Numbers a) 41000-030-50
- UDI/DI None
- Serial Numbers: 110120039437
- 110120039438
- 110120039439
- 110190044556
- 110190044557
- 110190044558
- 110190044559
- 110190044560
- 110190044561
- 110190044562
- 110190044563
- 110190044564
- 110190044565
- 110190044566
- 110190044567
- 110200045831
Distribution
Distribution scope not specified by the agency.
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