Recall Z-0553-2021— WELCH ALLYN, INC/MORTARA
Class II · Terminated
Class II FDA medical device recall by WELCH ALLYN, INC/MORTARA, initiated 2020-11-11, terminated 2023-08-08. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: The radio within the device can become disassociated with the wireless access point..
- Recalling firm
- WELCH ALLYN, INC/MORTARA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-11
- Terminated
- 2023-08-08
- Firm location
- Milwaukee, WI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.