🔍 RecallPedia

Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148

Class I - Dangerous
🏥 Medical Devices Recalled: May 3, 2024 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: N/A Serial Numbers: 41130 70284 41047 41196 41520 70068 70630 41024 41025 41051 41139 41143 41144 41235 41286 41327 41349 41367 41424 41432 41433 70099 70202 81073 41344 41042 41229 41457 41497 41413 84370 41080 70205 41295 70996 70589 70696 81021 41179 41041 41089 41189 41226 41287 70093 41311 70260 41464 41534 70652 41011 70067 70622 70769 70983
  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 Llc
Reason for Recall:
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in 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:

Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148

Product Codes/Lot Numbers:

UDI-DI: N/A Serial Numbers: 41130 70284 41047 41196 41520 70068 70630 41024 41025 41051 41139 41143 41144 41235 41286 41327 41349 41367 41424 41432 41433 70099 70202 81073 41344 41042 41229 41457 41497 41413 84370 41080 70205 41295 70996 70589 70696 81021 41179 41041 41089 41189 41226 41287 70093 41311 70260 41464 41534 70652 41011 70067 70622 70769 70983

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1843-2024

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