WELCH ALLYN, INC/MORTARA recalls Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device
Recalled Product
Q-Stress/XScribe. Q-Stress or XScribe is a diagnostic device capable of real time ECG display, heart rate measurement, ST analysis and ventricular ectopic beat detection using wired or wireless acquisition modules.
Hazard / Issue
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Issued by
FDA
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