🔍 RecallPedia

Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Class I - Dangerous
🏥 Medical Devices Recalled: February 21, 2018 Philips Medical Systems (Cleveland) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669
  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 Medical Systems (Cleveland) Inc
Reason for Recall:
Surview scan with tube current lower than 30 mA is unable to be initialized.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Product Codes/Lot Numbers:

Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1396-2018

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Philips Medical Systems (Cleveland)

Class I - Dangerous

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