Welch Allyn Inc Mortara

FDA Regulatory Profile

Welch Allyn Inc Mortara appears in FDA public data with 5 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0011-2022, Class II) was initiated on September 3, 2021.

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0011-2022Class IIELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), ModeSeptember 3, 2021
Z-1485-2021Class IIAM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - ProduMarch 31, 2021
Z-1484-2021Class IISurveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted softwarMarch 31, 2021
Z-1483-2021Class IIELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of tMarch 31, 2021
Z-1482-2021Class IIELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of tMarch 31, 2021