medical Class II Updated 2020-05-06

WELCH ALLYN, INC/MORTARA recalls T12. Incorporates wireless electrocardiographic technology t

Recalled 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.

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

Distribution: Nationwide (United States)
Lot/Code Info: Model Numbers: T12-XXX-XXXXX, T12S-XXX-XXXXX.
View official government recall

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