🔍 RecallPedia

Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

Class I - Dangerous
🏥 Medical Devices Recalled: June 30, 2025 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Numbers (REF): (1) 781153, (2) 781253; UDI-DI: (1) None, (2) None; Serial Numbers: (1) 23003, 23004, 23005, 23011, 23014, 23017, 23020, 23021, 23028, 23031, 23035, 23041, 34039, (2) 35004, 35006, 35007, 35011, 35015, 35016, 35019, 35020, 35021, 35022, 35028, 35035, 35049, 35050, 35061, 35063, 35067, 35068, 35069, 35070, 35074, 35075, 35076, 35081, 35083, 35084, 35085;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips North America
Reason for Recall:
The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;

Product Codes/Lot Numbers:

Model Numbers (REF): (1) 781153, (2) 781253; UDI-DI: (1) None, (2) None; Serial Numbers: (1) 23003, 23004, 23005, 23011, 23014, 23017, 23020, 23021, 23028, 23031, 23035, 23041, 34039, (2) 35004, 35006, 35007, 35011, 35015, 35016, 35019, 35020, 35021, 35022, 35028, 35035, 35049, 35050, 35061, 35063, 35067, 35068, 35069, 35070, 35074, 35075, 35076, 35081, 35083, 35084, 35085;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2201-2025

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