Cardiac Stress Testing Device May Produce Distorted ECG Readings
The XScribe CP Cardiac Stress Testing System (version 6) is being recalled because it may produce distorted electrocardiogram readings when the Source Consistency Filter is enabled, which could affect the accuracy of cardiac test results.
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 of a high-risk medical device used for cardiac diagnosis. Although no illnesses or injuries have been reported, the identified defect in ECG readings poses a risk of patient harm through misdiagnosis or missed cardiac conditions. This meets the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Baxter Healthcare Corporation is recalling the XScribe CP Cardiac Stress Testing System, version 6. The recall affects approximately 1,675 units that have been distributed globally, including to the United States, Puerto Rico, Canada, Australia, and numerous countries in Asia, Africa, Europe, and Latin America.
The device has been recalled due to a potential defect: it may produce distorted electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. Distorted ECG readings could result in misinterpretation of cardiac test results and may impact clinical decision-making.
Healthcare facilities and patients who have undergone cardiac stress testing with affected XScribe CP systems should contact their healthcare providers to determine whether their test results may have been affected. Facilities using these devices should check the product code and serial numbers against the FDA recall notice and follow remediation guidance from Baxter Healthcare Corporation.
The recalled product
- Product
- XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT Q
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device
- Hazard
- ecg-distortion
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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