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.
Recall
- Recall Number
- Z-0553-2021
- Event Number
- 86716
- Firm
- WELCH ALLYN, INC/MORTARA
- FEI Number
- 2183461
- Product Code
- DPS
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- November 11, 2020
- Terminated
- August 8, 2023
- Address
- 7865 N 86th St, Milwaukee, WI, 53224-3431
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.
The radio within the device can become disassociated with the wireless access point.
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 software to be used to update your affected units identified in Appendix C. o Enclosed in Appendix C is a list of impacted devices and serial numbers. Locate the devices in your possession and upgrade the software as soon as possible following the instructions in Appendix B or using the instructions provided on the USB flash drive. After the software is successfully upgraded, complete the enclosed Urgent Medical Device Correction Confirmation Form in Appendix C. Sign and return the form to [email protected]. Note: Instructions are provided in Appendix A to locate the serial number on the device if needed. o If technical assistance is needed during the installation process, please contact the appropriate regional technical support via phone or email using the contact information provided in the Contact Reference Person table below. o This notice should be sent to all members of your organization who need to be aware and/or to any organization where the potentially affected devices have been transferred. Transmission of this Urgent Medical Device Correction Letter: Please transfer this notice to other organization as appropriate. Please maintain awareness of this notice for an appropriate period to ensure effectiveness. Please note that this Urgent Medical Device Correction Notice is being made with the knowledge of the Food and Drug Administration (FDA). Adverse re
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.
1,009 units