🔍 RecallPedia

Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146

Class I - Dangerous
🏥 Medical Devices Recalled: April 25, 2023 Philips North America Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: (01)00884838104481(21) Serial Numbers: 540009 540008 540015 540012 540016 540017 540003 540004 540005 540006 540007 540001 540011 540000 540014 540013 540018 540010 540002
  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:
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146

Product Codes/Lot Numbers:

UDI-DI: (01)00884838104481(21) Serial Numbers: 540009 540008 540015 540012 540016 540017 540003 540004 540005 540006 540007 540001 540011 540000 540014 540013 540018 540010 540002

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2259-2023

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