FDAMarch 18, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.

What to do

FDA enforcement status: Terminated

Brands named

welch allyn inc mortarawelchwelch allyn

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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