Baxter recalls XScribe Cardiac Stress Testing System version 6 with specific model codes due to potential distortion in electrocardiogram readings when Source Consistency Filter is enabled.
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Baxter is recalling certain versions of their XScribe Cardiac Stress Testing System (version 6) because the Source Consistency Filter can cause inaccurate electrocardiogram readings. This may lead to incorrect heart condition assessments during stress tests. Affected units have specific model codes and serial numbers listed in the recall notice.
The Source Consistency Filter (SCF) in the system can cause distortion in electrocardiogram (ECG) readings when enabled. This may lead to incorrect interpretation of heart function during stress tests, potentially affecting diagnosis and treatment decisions.
Healthcare providers using the XScribe Cardiac Stress Testing System version 6 with specific model codes and serial numbers listed in the recall notice are most at risk. Patients using these systems for cardiac stress testing may receive inaccurate results.
Check if your XScribe Cardiac Stress Testing System version 6 has one of the listed model codes (XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX, XR-6AC-DXXXX, etc.) and the corresponding serial numbers provided in the recall notice.
Verify your XScribe Cardiac Stress Testing System version 6 has one of the listed model codes and serial numbers from the recall notice.
The Source Consistency Filter (SCF) can cause distortion in electrocardiogram (ECG) readings when enabled, potentially leading to inaccurate heart condition assessments during stress tests.
Check if your XScribe Cardiac Stress Testing System version 6 has one of the listed model codes (XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX, etc.) and the corresponding serial numbers provided in the recall notice.
The recall does not specify a remedy, so no action is required beyond checking if your product is affected. Baxter has not provided a fix or replacement.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0706-2024 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0706-2024 from Baxter. 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.
