Agency classClass IIOur severity:High FDA (Devices)·Z-0011-2022·Announced 2021-10-13

ELI 280 Resting Electrocardiographs Recalled Due to Device Malfunction

Welch Allyn Inc Mortara is recalling ELI 280 Resting Electrocardiographs due to device malfunction under specific operator workflows. The recall affects 14,630 units distributed nationwide and internationally.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall involves a risk-of-harm product (diagnostic device) with device malfunction, and no reported adverse events are documented in the source text. Per the severity rubric, this meets the criterion for Score 3 (High): 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Welch Allyn Inc Mortara is recalling multiple model variants of ELI 280 Resting Electrocardiographs due to device malfunction that occurs under specific operator workflows. The recall affects 14,630 units total.

The affected devices were manufactured from July 1, 2016, through July 1, 2021, with software versions 2.1.0 through 2.3.0 and serial numbers 116280503226 through 121250000503.

Distribution was nationwide, including Puerto Rico, and internationally to over 50 countries including Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Monaco, Morocco, Netherlands, New Zealand, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, and United Kingdom.

The recalled product

Product: ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX…
Manufacturer: Welch Allyn Inc Mortara
Category: Medical Device — Diagnostic Equipment
Hazard: device-malfunction
Affected units: 14,630

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 (1)

Software versions 2.1.0-2.3.0

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Welch Allyn Inc Mortara

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