Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0707-2024 — 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 QUICK CONNECT USB, 41

U.S. FDA — Device Enforcement · United States · 2023-12-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0707-2024
Date of alert
2023-12-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Baxter Healthcare Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
110120039437
Reported risk: Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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