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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 MRI Systems Recalled Due to Gradient Coil Fire and Smoke Risk

Agency Publication Date: November 21, 2023
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Summary

Philips North America is recalling approximately 860 MRI (Magnetic Resonance Imaging) systems, including several Achieva, Ingenia, and Intera models, because a component inside the Gradient Coil can fail. This defect can cause the machine to produce smoke or catch fire during use, posing a serious safety risk to patients and medical staff. The recall affects 520 Achieva 1.5T units, 102 Intera 1.5T units, and several other 1.5T system variations distributed globally. Consumers should not attempt to repair these systems themselves and should instead wait for professional service from the manufacturer.

Risk

A specific component within the Gradient Coil is prone to failure, which can lead to overheating and the generation of smoke or an active fire inside the medical facility. This poses risks of smoke inhalation, burns, and fire-related injuries to anyone in the vicinity of the device.

What You Should Do

  1. Identify if your facility uses any of the following Philips 1.5T MRI systems: Achieva, Achieva Conversion, Achieva Initial System, Ingenia CX, Intera, Intera Power/Pulsar, or SmartPath to dStream.
  2. Check the serial number of your device against the affected list; for example, Achieva 1.5T systems with serial numbers such as 21034, 32086, 33022, or 72322 are included in this recall.
  3. Review the Product Numbers associated with the recall, which include 781178, 781196, 781296, 781343, 781283, 781346, 781261, 781262, 781195, 781295, 781105, 781260, and 782112.
  4. Verify the Unique Device Identifier (UDI-DI) on your equipment, such as (01)00884838004108, (01)00884838009806, or (01)00884838095076 followed by the specific 21-digit serial suffix.
  5. Contact your healthcare provider or Philips North America at their Cambridge, MA headquarters to schedule a professional inspection and repair of the Gradient Coil component.
  6. For further instructions regarding equipment safety and potential remedy options, contact Philips North America or your local Philips service representative.
  7. Call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance and to report any incidents.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/repair

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

Affected Products

Product: Achieva 1.5T
Model / REF:
781178
781196
781296
781343
Lot Numbers:
Serial No. 21034-72322 (8524, 32039, 32052, 32083, 32087, 32097, etc.)
Product: Achieva 1.5T Conversion
Model / REF:
781283
781346
Lot Numbers:
Serial No. 39001-75092
Product: Achieva 1.5T Initial System
Model / REF:
781178
Lot Numbers:
Serial No. 21605
21695
Product: Ingenia 1.5T CX
Model / REF:
781261
781262
Lot Numbers:
Serial No. 77008-77137
Product: Intera 1.5T
Model / REF:
781195
781295
Lot Numbers:
Serial No. 18510-30315
Product: Intera 1.5T Power/Pulsar
Model / REF:
781105
Lot Numbers:
Serial No. 8187
Product: SmartPath to dStream for 1.5T
Model / REF:
781260
782112
Lot Numbers:
Serial No. 5447-32798

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93361
Status: Active
Manufacturer: Philips North America Llc
Sold By: Philips North America; Direct medical equipment sales
Manufactured In: United States
Units Affected: 7 products (520 units; 68 units; 2 units; 48 units; 102 units; 1 unit; 119 units)
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.