PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: July 17, 2024 Initiated: June 3, 2024 #Z-2323-2024

Product Description

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.

Reason for Recall

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.

Details

Units Affected
1 unit
Distribution
Distribution to Illinois.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
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.. Recalled by Baxter Healthcare Corporation. Units affected: 1 unit.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 17, 2024. Severity: Moderate. Recall number: Z-2323-2024.