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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 G7m Anesthesia Gas Modules Recalled Due to Pump Failure Risk

Agency Publication Date: October 1, 2024
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Summary

Philips North America is recalling 8,449 IntelliVue G7m Anesthesia Gas Modules (Product Number 866173) because a critical internal component may fail. The device's sample gas pump can stop working prematurely due to friction and wear, which triggers an "INOP" (inoperable) alarm. When this happens, the module can no longer measure anesthetic gases during medical procedures, potentially interrupting patient monitoring. This recall affects devices with serial numbers ranging from DE43800129 through DE43812627. Consumers should contact their healthcare provider or the manufacturer for instructions on how to handle affected units.

Risk

If the sample gas pump fails, the device will stop measuring anesthetic gas levels, which may prevent medical staff from accurately monitoring a patient's sedation during surgery. This loss of data could lead to serious medical complications if the failure occurs during a procedure and is not immediately addressed.

What You Should Do

  1. Check your device's product number and serial number to see if it is affected. This recall applies to IntelliVue G7m Anesthesia Gas Modules, Product Number 866173, with serial numbers DE43800129 through DE43812627.
  2. Verify the Unique Device Identifier (UDI-DI) on the product packaging, which should be 00884838051492 for the affected modules.
  3. If your module is within the affected range, contact Philips North America or your healthcare provider immediately to discuss the necessary corrective actions or repairs.
  4. Be prepared to respond to any technical "INOP" (inoperable) alarms on the device, as these indicate the gas measurement system has stopped working and requires attention.
  5. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and potential technical correction.

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

Affected Products

Product: IntelliVue G7m Anesthesia Gas Module, Product Number 866173
Model / REF:
866173
00884838051492
Lot Numbers:
Serial Numbers: DE43800129 through DE43812627

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95301
Status: Active
Manufacturer: Philips North America
Sold By: Philips North America; Medical equipment distributors
Manufactured In: United States
Units Affected: 8,449 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.