Welch Allyn Inc Mortara
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0011-2022 | Class II | ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Mode | September 3, 2021 |
| Z-1485-2021 | Class II | AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Produ | March 31, 2021 |
| Z-1484-2021 | Class II | Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition Module accessory. Impacted softwar | March 31, 2021 |
| Z-1483-2021 | Class II | ELI 380 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of t | March 31, 2021 |
| Z-1482-2021 | Class II | ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of t | March 31, 2021 |