Milwaukee, WI, United States
Welch Allyn Inc Mortara recalls
2 recalls recorded since 2018, most recently on 3 September 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 3 September 2021
- Reason
- 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 Republi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0011-2022
- 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-D
Terminated Class II Medical devices
- Recall started
- 31 March 2021
- Terminated
- 16 August 2024
- Reason
- Devices do not meet IEC 60601-2-27 requirements as labeled.
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, IN, LA, NC, NJ, NV, NY, OH, OK, TX, UT, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1484-2021, Z-1485-2021, Z-1482-2021, Z-1483-2021
- Surveyor S12/S19 Bedside Patient Monitor, 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.
- 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.
- ELI 280 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.
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.