FDA Medical Device Recalls (openFDA)
Welch Allyn Inc Mortara: ELI 280 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.
- Recall number
- Z-1482-2021
- Recalling firm
- Welch Allyn Inc Mortara
- Product
- ELI 280 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.
- Status
- Terminated
- Initiated
- 2021-03-31
- Posted
- not on file
- Terminated
- 2024-08-16
- Reason
- Devices do not meet IEC 60601-2-27 requirements as labeled.
- Root cause
- 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
- 99 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.
- Lot, serial or model codes
- Part Number: ELI280-LDB-ADAAX (Device Identifier: 732094265699); S/N: 117030550918 and 117030550919 Part Number: ELI280-LDD-AAABX (Device Identifier: 732094265682); S/N: 117260576403 Part Number: ELI280-LDX-ADABX (Device Identifier: 732094265675); S/N: 118240001697 and 118150627678 Part Number: ELI280-LDX-ADFBD (Device Identifier: 732094265644); 118230000580, 118230000570, 118230000584, 118230000569, 118230000572 118230000582, 118230000574, 118230000576, 118230000577, 118230000581, 118230000568, 118230000575, 118230000583, 118230000578, 118230000571, 118230000567, 118340001621, 118340001622, 118340001623, 118400001475, 118400001471, 118400001472, 118400001476, 118400001467, 118400001470, 118400001469, 118400001482, 118400001477, 118400001481, 118400001478, 118400001479, 118400001480, 118420000070, 118420000071, 118420000065, 118420000067, 118420000068, 118420000066, 118420000069, 118430000923, 118430000946, 118430000930, 118430000932, 118430000928, 119150000011, 119150000001, 119150000002, 119150000003, 119150000010, 119150000008, 119150000009, 119150000004, 119150000007, 119180000631, 119180000632, 119180000633, 119180001155, 119180001156, 119180001153, 119180001154, 119180001157, 119260000043, 119260000442, 119260000443, 119280001568, 119270000064, 119290001054, 119290001053, 119290001048, 119290001052, 119290001050, 119290001049, 119290001051, 119290001055, 119470001878, 119470001879, 119510000132, 119510000135, 119510000134, 119510000133, 120080000860, 120050001405, 118120622367, 118180633837, 118180633838, 118180633839, 118180633840, 118190635342, 118190635353 Part Number: ELI280-LDX-ADFBG (Device Identifier: 732094319941); S/N: 119480000195, 119480000191, 119480000193, 119480000194, 119480000192
- 510(k) numbers
- ["K122073"]
- PMA numbers
- not on file
- Product code
- DPS
- Firm FEI
- 2183461
- Firm city
- Milwaukee
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28