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Welch Allyn Inc Mortara FDA Recalls
5 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELClass IISep 3, 2021The devices malfunction under specific operator workflows. |
| ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version Class IIMar 31, 2021Devices do not meet IEC 60601-2-27 requirements as labeled. |
| Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted software version of the AM1Class IIMar 31, 2021Devices do not meet IEC 60601-2-27 requirements as labeled. |
| AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated Class IIMar 31, 2021Devices do not meet IEC 60601-2-27 requirements as labeled. |
| ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version Class IIMar 31, 2021Devices do not meet IEC 60601-2-27 requirements as labeled. |