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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/Monitoring Devices

Philips North America: IntelliVue Patient Monitors Recalled for Loss of Electrical Grounding

Agency Publication Date: September 25, 2024
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Summary

Philips North America is recalling 545 IntelliVue Patient Monitors, including models MX400, MX430, MX450, MX500, and MX550, because of a defect where the ground bolt in the power supply can break. This defect was discovered during production and can lead to a loss of electrical grounding, which may interfere with the device's ability to handle electromagnetic emissions. Only devices shipped after April 26, 2024, are affected by this recall. Consumers should contact Philips or their healthcare provider for further instructions on how to handle affected monitors.

Risk

A broken ground bolt causes a loss of electrical grounding, which can negatively affect the monitor's electromagnetic immunity. This could lead to device malfunction or interference with other medical equipment in the vicinity, potentially impacting patient monitoring accuracy.

What You Should Do

  1. Identify if you have an IntelliVue Patient Monitor model MX400 (866060), MX430 (866061), MX450 (866062), MX500 (866064), or MX550 (866066).
  2. Check the manufacturing date located on the back of your monitor; only devices shipped after April 26, 2024, are included in this recall.
  3. Verify your device against the following UDI-DI codes: 00884838038752 (MX400), 00884838057562 (MX430), 00884838038769 (MX450), 00884838038776 (MX500), and 00884838038783 (MX550).
  4. Contact your healthcare provider or Philips North America at 222 Jacobs St, Cambridge, MA 02141-2296 for specific instructions regarding the inspection or repair of the power supply ground bolt.
  5. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report adverse events.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification via letter.

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

Affected Products

Product: IntelliVue Patient Monitor MX400
Model / REF:
866060
UPC Codes:
00884838038752
Date Ranges: Shipped after 26-April-2024
Product: IntelliVue Patient Monitor MX430
Model / REF:
866061
UPC Codes:
00884838057562
Date Ranges: Shipped after 26-April-2024
Product: IntelliVue Patient Monitor MX450
Model / REF:
866062
UPC Codes:
00884838038769
Date Ranges: Shipped after 26-April-2024
Product: IntelliVue Patient Monitor MX500
Model / REF:
866064
UPC Codes:
00884838038776
Date Ranges: Shipped after 26-April-2024
Product: IntelliVue Patient Monitor MX550
Model / REF:
866066
UPC Codes:
00884838038783
Date Ranges: Shipped after 26-April-2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95295
Status: Active
Manufacturer: Philips North America
Sold By: Global Distribution
Manufactured In: United States
Units Affected: 545 devices
Distributed To: Nationwide

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.