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.
This recall is currently active, issued July 10, 2024. It was issued by Baxter Healthcare Corporation.
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- June 3, 2024
- Posted
- July 10, 2024
- Recall Number
- Z-2323-2024
- Quantity
- 1 unit
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Distribution to Illinois.
Lot / Code Info
UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024
Root Cause
Employee error
Action Taken
On 06/03/2024, Baxter Healthcare's Customer Service team contacted the consignee, via telephone call, to discuss the recall action and request the affected unit be returned to Baxter.