ELI 380 Electrocardiograph recall
ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage…
Why was ELI 380 Electrocardiograph recalled?
Devices do not meet IEC 60601-2-27 requirements as labeled.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage…
- Recalling firm
- Welch Allyn Inc Mortara
- 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.
- Recall date
- April 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)