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WELCH ALLYN, INC/MORTARA recalls T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and RF transmission of s
Recalled May 6, 2020 · FDA recall Z-1813-2020 · WELCH ALLYN, INC/MORTARA
Hazard
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. · FDA Class II
Units
78,521 units total
Sold at
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.
Description
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
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.
Manufacturer(s)
WELCH ALLYN, INC/MORTARA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →