Recall Z-2323-2024— Baxter Healthcare Corporation

Name: FDA recall Z-2323-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-03

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2024-06-03. It names one FDA 510(k) clearance: K141582. Product: 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..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-06-03
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K141582 — CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTIONWelch Allyn·cleared 2014-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.