Recall Z-1817-2020— WELCH ALLYN, INC/MORTARA

Name: FDA recall Z-1817-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-18

Class II · Terminated

Class II FDA medical device recall by WELCH ALLYN, INC/MORTARA, initiated 2020-03-18, terminated 2026-02-09. It names one FDA 510(k) clearance: K152944. 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.. Reason: Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment..

Recalling firm: WELCH ALLYN, INC/MORTARA
Classification: Class II
Status: Terminated
Initiated: 2020-03-18
Terminated: 2026-02-09
Firm location: Milwaukee, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K152944 — Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing SystemsMortara Instrument, Inc.·cleared 2016-01-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.