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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

Philips North America Llc: Philips Magnetic Resonance (MR) Systems Recalled for Fire Risk

Agency Publication Date: May 17, 2024
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Summary

Approximately 8,631 Philips Magnetic Resonance (MR) systems, including Achieva, Ingenia, Intera, and Panorama models, are being recalled because an electrical connection can become loose. This defect can create a hotspot that leads to overheating, smoke, or fire in the hospital's technical room. If you are using one of these systems, please contact your healthcare provider or Philips North America for further instructions.

Risk

A loose terminal connection in the global Mains Distribution Unit (g-MDU) can cause electrical resistance and overheating. This creates a high fire risk that could trigger smoke alarms or lead to a fire in the hospital's technical facility.

What You Should Do

  1. Check your device serial number and model number against the affected list, which includes Achieva 1.5T/3.0T (Model 781296, 781343, 781178, 781345, 781344, 781278, 781277, 781177, 781477, 781479, 781253), Ingenia 1.5T/3.0T (Model 782140, 782115, 782101, 781396, 781341, 781315, 781262, 781261, 781347, 782103, 781377, 781342, 782105, 781271, 782139, 782133, 782108, 781359, 782138, 782109, 781356, 781358, 782118), and Intera/Panorama models.
  2. Review the notification letter sent by Philips to identify if your specific installation is at risk of terminal connection failure.
  3. Contact Philips North America LLC or your local authorized service representative immediately to schedule a technical inspection or corrective maintenance.
  4. If you detect smoke or any signs of electrical burning near the technical room, follow hospital emergency protocols and contact the manufacturer's technical support.
  5. Call the FDA at 1-888-463-6332 if you have additional safety concerns or questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Corrective Action

How to: Contact your healthcare provider or the manufacturer for further instructions and potential corrective maintenance.

Affected Products

Product: Achieva 1.5T Magnetic Resonance (MR) system
Model / REF:
781296
781343
Lot Numbers:
Serial Number 32307
Serial Number 33454
Serial Number 33668
Serial Number 32302
Product: Achieva 1.5T Conversion Magnetic Resonance (MR) system
Model / REF:
781283
781346
Lot Numbers:
Serial Number 39011
Serial Number 39056
Product: Achieva 3.0T Magnetic Resonance (MR) system
Model / REF:
781345
781344
781278
781277
781177
Lot Numbers:
Serial Number 24079
Serial Number 34231
Product: Ingenia 1.5T Magnetic Resonance (MR) system
Model / REF:
782140
782115
782101
781396
781341
781315
Lot Numbers:
Serial Number 61019
Serial Number 61140
Product: Ingenia 3.0T Magnetic Resonance (MR) system
Model / REF:
782103
781377
781342
Lot Numbers:
Serial Number 85106
Serial Number 71011
Product: Intera 1.5T Magnetic Resonance (MR) system
Model / REF:
781295
Lot Numbers:
Serial Number 30199
Serial Number 30200
Product: MR 5300 Magnetic Resonance (MR) system
Model / REF:
782152
782110
Lot Numbers:
Serial Number 79113
Serial Number 79118
Product: Panorama HFO Magnetic Resonance (MR) system
Model / REF:
781350
Lot Numbers:
Serial Number 37019
Serial Number 37067

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94508
Status: Active
Manufacturer: Philips North America Llc
Sold By: specialty medical equipment distributors; direct sales to hospitals
Manufactured In: United States
Units Affected: 27 products (1585 units; 140 units; 2 units; 386 units; 1 unit; 35 units; 56 units; 2262 units; 139 units; 1517 units; 350 units; 328 units; 509 units; 1 unit; 200 units; 81 units; 118 units; 81 units; 10 units; 2 units; 2 units; 617 units; 3 units; 200 units; 1 unit; 4 units; 1 unit)
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.