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.
FDA Recall Z-2323-2024 · Posted 2024-07-10
Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeDPS
Date Initiated2024-06-03
Product Quantity1 unit
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Distribution to Illinois.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.