CLASS II Device recall · Reported 28 Apr 2021 · FDA Enforcement Report

ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory recalled

Welch Allyn Inc Mortara is recalling ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory, distributed nationwide in the US. The recall was initiated on 31 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 120090001354 Part Number: ELI380-DAX3X (Device Identifier: 812345026757); S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469 Part Number: ELI380-DBX32 (Device Identifier: 732094265262); S/N: 118180634420 Part Number: ELI380-DCX32 (Device Identifier: 732094265187); S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570

Quantity recalled27 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-1483-2021
FDA event ID: 87686
Recalling firm: Welch Allyn Inc Mortara, Milwaukee, WI
Classification: Class II
Status: Terminated
Recall initiated: 31 Mar 2021
FDA classified: 22 Apr 2021
Reported: 28 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

31 Mar 2021	Recall initiated by company
22 Apr 2021	Classified by FDA	+22 days
28 Apr 2021	Published in enforcement report	+6 days

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

Reason for recall

Devices do not meet IEC 60601-2-27 requirements as labeled.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations.

Where it was distributed

US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.

Nationwide California Colorado Florida Georgia Indiana Louisiana North Carolina New Jersey Nevada New York Ohio Oklahoma Texas Utah Virginia

Questions about this recall

Why was it recalled?

Devices do not meet IEC 60601-2-27 requirements as labeled.

Which lots are affected?

Part Number: ELI380-ACX32 (Device Identifier: 732094265415); S/N: 118490001284, 119150000588, 120090001355, 120090001354 Part Number: ELI380-DAX3X (Device Identifier: 812345026757); S/N: 117120557018, 117120557019, 117120557020, 117120557021, 117230571942, 117230571943, 117270577469 Part Number: ELI380-DBX32 (Device Identifier: 732094265262); S/N: 118180634420 Part Number: ELI380-DCX32 (Device Identifier: 732094265187); S/N: 118340001074, 118340001074, 118340001075, 118500001332, 118460001178, 119150000120, 119210000774, 119290000580, 119520000194, 120080001509, 120080001510, 120100000310, 120080001511, 120110002478, 120170000570

Where was it sold?

US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.

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.

Other products in this recall event

3 other products · FDA event 87686

This product is part of a recall event; the main page for the event is Surveyor S12/S19 Bedside Patient Monitor recalled.

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

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 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
16 Dec 2020Device	CLASS II	ELI 380 Electrocardiograph recalled by Welch Allyn, Inc/mortara	Welch Allyn Inc/Mortara	Other	Nationwide

Other Surgical Instruments recalls

All 3,902

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21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Medline surgical convenience kits labeled as recalled	Medline Industries	Packaging Defects	Nationwide
21 Oct 2026Device	CLASS II	Scout MD recalled by Merit Medical Systems	Merit Medical Systems	Other	7 states
21 Oct 2026Device	CLASS II	Convenience Kits containing Conmed AirSeal Access Ports recalled	Medline Industries	Packaging Defects	Nationwide