The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1483-2021·Announced 2021-04-28

Welch Allyn ELI 380 Electrocardiograph Recalled for IEC 60601-2-27 Non-Compliance

Welch Allyn Inc Mortara is recalling 27 ELI 380 Electrocardiographs because they do not meet IEC 60601-2-27 requirements as labeled.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or fatalities, indicating a theoretical or low-risk hazard.

Plain-English summary

Welch Allyn Inc Mortara is recalling 27 units of the ELI 380 Electrocardiograph, which includes the AM12M Acquisition Module accessory. The specific software version of the AM12M affected by this recall is version 1.5.1. The devices are indicated for use on adult and pediatric populations.

The recall was initiated because the devices do not meet IEC 60601-2-27 requirements as labeled. This standard pertains to the safety of electrocardiographic equipment. The recall covers units distributed nationwide in the United States, specifically in the states of California, Colorado, Florida, Georgia, Indiana, Louisiana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Texas, Utah, and Virginia.

Healthcare facilities and users should stop using the affected devices and contact Welch Allyn Inc Mortara for further instructions on remediation or replacement. The recall involves specific part numbers and serial numbers, which are detailed in the official FDA recall notice Z-1483-2021.

The recalled product

Product
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.
Manufacturer
Welch Allyn Inc Mortara
Category
Medical Device — Cardiology
Hazard
Affected units
27

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Welch Allyn Inc Mortara under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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