Recall Z-1813-2020— WELCH ALLYN, INC/MORTARA

Name: FDA recall Z-1813-2020
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: K081800. Product: T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.. 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

K081800 — T12S TELEMETRY TRANSMITTERMortara Instrument, Inc.·cleared 2008-09-24

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

T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of simultaneous 12-lead ECG data with diagnostic quality while allowing the patient to be ambulatory.

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.