ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
Reported: December 16, 2020 Initiated: November 11, 2020 #Z-0553-2021
Product Description
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.
Reason for Recall
The radio within the device can become disassociated with the wireless access point.
Details
- Recalling Firm
- WELCH ALLYN, INC/MORTARA
- Units Affected
- 1,009 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IN, KS, KY, MA, MD, MI, MO, MT, NC, ND, NH, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV, WY and the countries of Australia, Canada, Czech, Finland, GB, Germany, Italy, Kuwait, Netherlands, New Zealand, Norway, Qatar, Switzerland, United Arab Emirates, United Kingdom.
- Location
- Milwaukee, WI
Frequently Asked Questions
What product was recalled? ▼
ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead.. Recalled by WELCH ALLYN, INC/MORTARA. Units affected: 1,009 units.
Why was this product recalled? ▼
The radio within the device can become disassociated with the wireless access point.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 16, 2020. Severity: Moderate. Recall number: Z-0553-2021.
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