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U.S. Department of Health and Human Services

Class 2 Device Recall T12

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 Class 2 Device Recall T12see related information
Date Initiated by FirmMarch 18, 2020
Date PostedApril 29, 2020
Recall Status1 Completed
Recall NumberZ-1813-2020
Recall Event ID 85297
510(K)NumberK081800 
Product Classification Electrocardiograph - Product Code DPS
ProductT12. 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.
Code Information Model Numbers: T12-XXX-XXXXX, T12S-XXX-XXXXX.
Recalling Firm/
Manufacturer		 WELCH ALLYN, INC/MORTARA
7865 N 86th St
Milwaukee WI 53224-3431
For Additional Information Contact
888-667-8272
Manufacturer Reason
for Recall		Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
FDA Determined
Cause 2		Device Design
ActionWelch 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.
Quantity in Commerce78,521 units total
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = DPS
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