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U.S. Department of Health and Human Services

Class 2 Device Recall ELI 380 Electrocardiograph

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  Class 2 Device Recall ELI 380 Electrocardiograph see related information
Date Initiated by Firm November 11, 2020
Create Date December 09, 2020
Recall Status1 Terminated 3 on August 08, 2023
Recall Number Z-0553-2021
Recall Event ID 86716
Product Classification Electrocardiograph - Product Code DPS
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.
Code Information Part Number Device Identifier ELI380-ABS12 00732094265545 ELI380-ABX12 00732094265514 ELI380-ACQ12 00732094319439 ELI380-ACS11 00812345026313 ELI380-ACX11 00812345024531 ELI380-ACX12 00732094265439 ELI380-ACX21 00812345024562 ELI380-ACX22 00732094265422 ELI380-ACX32 00732094265415 ELI380-DAS44 00732094265354 ELI380-DBX12 00732094265286 ELI380-DBX22 00732094265279 ELI380-DCP12 00732094301670 ELI380-DCQ11 00732094307870 ELI380-DCS11 00812345026917 ELI380-DCS12 00732094265248 ELI380-DCS21 00812345026924 ELI380-DCS43 00812345026948 ELI380-DCT12 00732094265217 ELI380-DCX11 00812345026979 ELI380-DCX12 00732094265200 ELI380-DCX21 00812345026986 ELI380-DCX22 00732094265194 ELI380-DCX32 00732094265187 ELI380-DCX43 00812345027006
Recalling Firm/
Manufacturer		 WELCH ALLYN, INC/MORTARA
7865 N 86th St
Milwaukee WI 53224-3431
For Additional Information Contact Mark Elliott
414-354-1600
Manufacturer Reason
for Recall		 The radio within the device can become disassociated with the wireless access point.
FDA Determined
Cause 2		 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 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 mod1319@hillrom.com. 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
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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