FDA-Device2024-07-17Class II
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
Baxter Healthcare Corporation
Hazard
During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the vicinity or the device itself may be vulnerable to EMI resulting in device malfunction or unavailability.
Sold states
Distribution to Illinois.
Affected count
1 unit
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2323-2024Don't want to check this manually?
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