The Recall Desk
ModerateFDA (Devices)·Z-0553-2021·Announced 2020-12-16

Welch Allyn ELI 380 Electrocardiograph Recalled for Wireless Disconnection

Welch Allyn is recalling 1,009 ELI 380 Electrocardiographs because the internal radio can disconnect from the wireless access point.

What this means for you

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 hospitalizations, fitting the criteria for a moderate severity rating.

Plain-English summary

Welch Allyn, Inc/Mortara is recalling 1,009 units of the ELI 380 Electrocardiograph. The device is a high-performance, multichannel resting electrocardiograph intended to simultaneously acquire data from each lead.

The recall was initiated because the radio within the device can become disassociated with the wireless access point. This defect may affect the device's ability to maintain a stable wireless connection.

The affected devices were distributed worldwide, including in the United States and various international markets. Users should contact Welch Allyn for further instructions on how to address the issue.

The recalled product

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.
Manufacturer
WELCH ALLYN, INC/MORTARA
Category
Medical Device — Cardiology
Hazard
Affected units
1,009

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Related recalls

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