Welch Allyn ELI 380 Electrocardiograph Recalled for IEC 60601-2-27 Non-Compliance
Welch Allyn Inc Mortara is recalling 27 ELI 380 Electrocardiographs because they do not meet IEC 60601-2-27 requirements as labeled.
- 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.
- Category
- Medical Device
- Distribution
- Distributed nationwide