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.
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 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
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