—#208382

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.

FDA product code: DPS — Electrocardiograph
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K141582
Affected lot / code info: UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024

Why it was 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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Distribution to Illinois.

Timeline

Recall initiated: 2024-06-03
Posted by FDA: 2024-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208382. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.