Recall Z-1483-2021
Welch Allyn Inc Mortara · initiated March 31, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
Devices do not meet IEC 60601-2-27 requirements as labeled.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1483-2021
- Initiated
- March 31, 2021
- Terminated
- August 16, 2024
- Product code
- DPS – Electrocardiograph
- Quantity
- 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.
- Recalling firm
- Welch Allyn Inc Mortara, Milwaukee, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1482-2021 Class II | ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software…Devices do not meet IEC 60601-2-27 requirements as labeled. | 03/31/2021Terminated |
| Z-1484-2021 Class II | Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory.…Devices do not meet IEC 60601-2-27 requirements as labeled. | 03/31/2021Terminated |
| Z-1485-2021 Class II | AM12M Acquisition Module accessory. Impacted software version of the AM12M is version…Devices do not meet IEC 60601-2-27 requirements as labeled. | 03/31/2021Terminated |