CLASS II Device recall · Reported 16 Dec 2020 · FDA Enforcement Report

ELI 380 Electrocardiograph recalled by Welch Allyn, Inc/mortara

Welch Allyn Inc/Mortara is recalling ELI 380 Electrocardiograph, distributed nationwide in the US. The recall was initiated on 11 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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

Quantity recalled1,009 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0553-2021
FDA event ID: 86716
Recalling firm: Welch Allyn Inc/Mortara, Milwaukee, WI
Classification: Class II
Status: Terminated
Recall initiated: 11 Nov 2020
FDA classified: 9 Dec 2020
Reported: 16 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

11 Nov 2020	Recall initiated by company
9 Dec 2020	Classified by FDA	+28 days
16 Dec 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The radio within the device can become disassociated with the wireless access point.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Indiana Kansas Kentucky Massachusetts Maryland Michigan Missouri Montana North Carolina North Dakota New Hampshire

Questions about this recall

Why was it recalled?

The radio within the device can become disassociated with the wireless access point.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Welch Allyn Inc/Mortara

All 16

Reported	Class	Recall	Company	Reason	Where
13 Oct 2021Device	CLASS II	ELI, Burdick and McKesson brand 280 Resting recalledMcKesson	Welch Allyn Inc Mortara	Device Malfunction	Nationwide
28 Apr 2021Device	CLASS II	ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory recalled	Welch Allyn Inc Mortara	Device Malfunction	Nationwide
28 Apr 2021Device	CLASS II	ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory recalled	Welch Allyn Inc Mortara	Device Malfunction	Nationwide
28 Apr 2021Device	CLASS II	AM12M Acquisition Module accessory recalled by Welch Allyn Inc Mortara	Welch Allyn Inc Mortara	Device Malfunction	Nationwide
28 Apr 2021Device	CLASS II	Surveyor S12/S19 Bedside Patient Monitor recalled	Welch Allyn Inc Mortara	Device Malfunction	Nationwide

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