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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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Critical RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips North America Llc: Panorama 1.0T HFO MR Systems Recalled for Potential Gas Pressure Buildup

Agency Publication Date: December 14, 2023
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Summary

Philips North America Llc has recalled approximately 342 Panorama 1.0T HFO Magnetic Resonance (MR) Systems globally, including 150 units in the United States, due to a risk of excessive helium gas pressure buildup. This issue occurs when a blockage in the system prevents helium from venting properly during a magnet quench (a sudden loss of superconductivity). The buildup can cause the structural components of the MRI machine to fail or burst, potentially releasing helium gas into surrounding rooms or throwing debris. Consumers should contact Philips or their healthcare facility management to ensure their system is inspected for potential blockages.

Risk

If the MRI system's venting path is blocked, high-pressure helium gas can cause the machine to fail structurally. This poses severe risks including chemical exposure to helium, physical injury from flying debris, and asphyxia (suffocation) if helium displaces oxygen in the room.

What You Should Do

  1. Identify if your facility uses a Panorama 1.0T HFO Magnetic Resonance (MR) System with model numbers 781250 or 781350.
  2. Check the serial number of your MR system; this recall applies to all serial numbers for these specific models.
  3. Contact Philips North America Llc immediately to discuss the safety notice and schedule any necessary inspections or maintenance to ensure the venting system is clear of blockages.
  4. If you are a patient scheduled for an MRI on this specific system, contact your healthcare provider to discuss the safety of your upcoming procedure.
  5. Contact your healthcare provider or Philips at the contact information provided by the manufacturer for further instructions regarding system safety and potential corrective actions.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer inspection and guidance

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

Affected Products

Product: Panorama 1.0T HFO, Magnetic Resonance (MR) System (Model 781250)
Model / REF:
781250
Product: Panorama 1.0T HFO, Magnetic Resonance (MR) System (Model 781350)
Model / REF:
781350

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93454
Status: Active
Manufacturer: Philips North America Llc
Sold By: Authorized medical device distributors; Direct sales to healthcare facilities
Manufactured In: United States
Units Affected: 150 US; 192 ROW
Distributed To: Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

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.