🔍 RecallPedia

Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Class I - Dangerous
🏥 Medical Devices Recalled: March 24, 2016 Philips Medical Systems (Cleveland) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model #: 728240; Serial #s: 3100, 3236, 5043, 5047, 5280, 5345, 5390, 5395, 5413, 5430, 5476, 5495, 5499, 5500, 5512, 6007, 6009, 6013, 6032, 6041, 6045, 6049, 6051, 6058, 6062, 6064, 6066, 6067, 6070, 6071, 6077, 6080, 6081, 6084, 6089, 6095, 6098, 6100, 6106, 6109, 6113, 6115, 6116, 6119, 6120, 6123, 6124, 6131, 6132, 6134, 6141, 6144, 6155, 6161, 6162.
  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:
Software defect causing intermittently slow response of Host.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Product Codes/Lot Numbers:

Model #: 728240; Serial #s: 3100, 3236, 5043, 5047, 5280, 5345, 5390, 5395, 5413, 5430, 5476, 5495, 5499, 5500, 5512, 6007, 6009, 6013, 6032, 6041, 6045, 6049, 6051, 6058, 6062, 6064, 6066, 6067, 6070, 6071, 6077, 6080, 6081, 6084, 6089, 6095, 6098, 6100, 6106, 6109, 6113, 6115, 6116, 6119, 6120, 6123, 6124, 6131, 6132, 6134, 6141, 6144, 6155, 6161, 6162.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2370-2016

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