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U.S. Department of Health and Human Services

Class 2 Device Recall ELI 380

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  Class 2 Device Recall ELI 380 see related information
Date Initiated by Firm March 31, 2021
Create Date April 22, 2021
Recall Status1 Completed
Recall Number Z-1483-2021
Recall Event ID 87686
510(K)Number K142105  
Product Classification Electrocardiograph - Product Code DPS
Product ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.
Code Information Part Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 120090001354  Part Number: ELI380-DAX3X (Device Identifier: 812345026757); S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469  Part Number: ELI380-DBX32 (Device Identifier: 732094265262); S/N: 118180634420  Part Number: ELI380-DCX32 (Device Identifier: 732094265187); S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570  
Recalling Firm/
Manufacturer		 Welch Allyn Inc Mortara
7865 N 86th St
Milwaukee WI 53224-3431
For Additional Information Contact Welch Allyn Technical Support
888-667-8272
Manufacturer Reason
for Recall		 Devices do not meet IEC 60601-2-27 requirements as labeled.
FDA Determined
Cause 2		 Process control
Action Recall notification letters were mailed to customers notifying them of the potential issue with recommended actions beginning April 7, 2021. The notification letter includes an acknowledgement form that must be returned to the recalling firm. Once the customer confirms the impacted units are in possession, the recalling firm will arrange for an exchange AM12M to be provided. The recalled unit will be returned to the recalling firm's service center for processing.
Quantity in Commerce 27 units
Distribution US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DPS and Original Applicant = MORTARA INSTRUMENT, INC
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