# FDA recall Z-0011-2022

> **Welch Allyn Inc Mortara** · Class II · device recall initiated 2021-09-03.

## 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,   ELI280-DBA-AAFBD,	ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX,    MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX,   ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX,    ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX,    ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD,    ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF,    MLBUR280-W1X,	 ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX,    ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX,   ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX,    ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, 

## Reason for recall

The devices malfunction under specific operator workflows.

## Distribution

Distribution was nationwide, including Puerto Rico.    Foreign distribution was made to Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Czechia, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guatemala, Hongkong, 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, The Netherlands, Trinidad and Tobago, Turkey, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-0011-2022
- **Recalling firm:** Welch Allyn Inc Mortara
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-03
- **Report date:** 2021-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milwaukee, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0011-2022

## Citation

> AI Analytics. FDA recall Z-0011-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0011-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*