WELCH ALLYN, INC/MORTARA 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
WELCH ALLYN, INC/MORTARA
Lot Codes / Batch Numbers
Model Numbers: T12-XXX-XXXXX, T12S-XXX-XXXXX.
Products Sold
Model Numbers: T12-XXX-XXXXX, T12S-XXX-XXXXX.
WELCH ALLYN, INC/MORTARA is recalling T12. Incorporates wireless electrocardiographic technology to achieve the real-time acquisition and due to Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
Recommended Action
Per FDA guidance
Welch Allyn notified customers on 2/19/2020 via "Voluntary Medical Device Correction Welch Allyn Patient Cables or Lead Sets". The recall letter identified the affected product and stated the reason for the recall. The firm also requested the distributors to immediately notify accounts if the product was further distributed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026