WELCH ALLYN, INC/MORTARA recalls T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of…

Recall date

March 18, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1813-2020

FDA classification

Class II

Brand / firm

WELCH ALLYN, INC/MORTARA

Sold / distributed

US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.