Baxter Healthcare recalls XScribe CP Cardiac Stress Testing System version 6 with specific product codes and serial numbers due to potential distortion in electrocardiogram readings when Source Consistency Filter is enabled. No immediate action required for most users.
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Baxter Healthcare is recalling version 6 of their XScribe CP Cardiac Stress Testing System because it can cause distortion in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. This could lead to inaccurate heart test results. The recall affects specific product models and serial numbers listed in the notice.
The system's Source Consistency Filter (SCF) can cause distortion in electrocardiogram (ECG) readings when enabled. This may lead to inaccurate heart test results, but the risk is not immediate or severe for most users as the issue only occurs under specific conditions.
Healthcare providers using the XScribe CP Cardiac Stress Testing System version 6 with specific product codes and serial numbers listed in the recall notice. Most users are not affected as the issue only occurs when the Source Consistency Filter is enabled.
Check if your XScribe CP Cardiac Stress Testing System version 6 has one of the listed product codes (e.g., X-SCRIBE CPI KIT WIRELESS USB 608 MHz) or serial numbers provided in the recall notice. The recall includes specific model numbers and serial ranges.
Verify if your device matches the product codes or serial numbers listed in the recall notice.
The recall indicates a potential for ECG distortion when the Source Consistency Filter is enabled, but it does not pose an immediate risk of injury or serious harm. The hazard is low risk as it only affects specific conditions.
No immediate action is required. The recall does not mandate stopping use; it only identifies a potential issue that may need attention if the Source Consistency Filter is enabled.
Check if your device has one of the listed product codes (e.g., X-SCRIBE CPI KIT WIRELESS USB 608 MHz) or serial numbers provided in the recall notice.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0707-2024 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-0707-2024 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
