Recall Z-0553-2021 ยท DPS Electrocardiograph
WELCH ALLYN, INC/MORTARA
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.
| Date | Nov 11, 2020 |
| Status | Terminated |
| Reason | The radio within the device can become disassociated with the wireless access point. |
| Root cause | Software design |
| Action | The products associated with this Urgent Medical Device Correction letter were manufactured between June 03, 2019 and July 27, 2020. A list of the affected part numbers is provided in Table 1. Action to be taken by the user: o If an ECG test is needed when there is no wireless connection, follow the user manual and acquire an ECG using the STAT ECG mode. The operating software installed on the ELI380 Resting Electrocardiograph requires to be upgraded to version 2.4.3 in order to address this issue. Included with this Urgent Medical Device Correction letter is a USB flash drive with the update |
| Quantity | 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, Kuwai |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.