FDAClass IIJuly 17, 2024

Welch Allyn CP150 Electrocardiograph with Spirometry recall

Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use…

Why was Welch Allyn CP150 Electrocardiograph with Spirometry 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI: 00732094177640. Product Code: CP150A-1ENB. Serial Number: 100013892024

Product
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use…
Recalling firm
Baxter Healthcare Corporation
Quantity
1 unit
Distribution
Distribution to Illinois.
Recall date
July 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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