FDA Recall
Open, Classified
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.
Recall: Z-2323-2024
·
Initiated June 3, 2024
Recall
- Recall Number
- Z-2323-2024
- Event Number
- 94805
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- DPS
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- June 3, 2024
- Posted
- July 10, 2024
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
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
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.
Action
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.
Distribution
Distribution to Illinois.
Quantity
1 unit