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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Baxter Healthcare Corporation: Welch Allyn CP150 Electrocardiograph Recalled for Missing EMI Component

Agency Publication Date: July 10, 2024
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Summary

Baxter Healthcare Corporation is recalling one unit of the Welch Allyn CP150 Electrocardiograph with Spirometry Option (Product Code CP150A-1ENB) because a critical part called an Electromagnetic Interference (EMI) absorber was not installed during manufacturing. This device is used by doctors to check and monitor heart function. Without this component, the device may fail to work correctly or could interfere with other nearby medical equipment, potentially leading to incorrect diagnoses or treatment delays. This recall affects only a single unit with serial number 100013892024, which was distributed in Illinois.

Risk

The missing EMI absorber can lead to electronic interference that causes the device to malfunction or stop working. It may also leak electromagnetic signals that interfere with the performance of other life-saving medical devices located in the same room.

What You Should Do

  1. Check your device to see if it is the Welch Allyn CP150 Electrocardiograph with Spirometry Option, specifically Product Code CP150A-1ENB.
  2. Verify the serial number on the device label; this recall only applies to Serial Number 100013892024.
  3. Contact your healthcare provider or Baxter Healthcare Corporation immediately to arrange for a corrective action or device inspection if you have the affected unit.
  4. Call the FDA's medical device hotline for any additional questions at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer corrective action

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Welch Allyn CP150 Electrocardiograph with Spirometry Option
Model / REF:
CP150A-1ENB
Serial Number: 100013892024
UPC Codes:
00732094177640
Lot Numbers:
CP150A-1ENB

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94805
Status: Active
Manufacturer: Baxter Healthcare Corporation
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 1 unit
Distributed To: Illinois

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.