🔍 RecallPedia

Brilliance CT 64. 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.

Class I - Dangerous
🏥 Medical Devices Recalled: March 16, 2015 Philips Medical Systems (Cleveland) Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    System Code #, 728231, Serial #, 9568, 9758, 10097, 10143, 10267, 10269, 10275, 10427, 10436, 10521, 10545, 10579, 10622, 90097, 90218, 95203, 95319, 95328, 95362, 95369, 95391, 95414, 95427, 95433, 95471, 95486, 95544, 95586, 95604, 95605, 95617, 95628, 95632, 95640, 95672, 95752, 95754 & 95757.
  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:
The firm was informed that while raising the patient couch on the system to perform an exam, the couch unexpectedly descended to the lowest point without being commanded to do so.
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 64. 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.

Product Codes/Lot Numbers:

System Code #, 728231, Serial #, 9568, 9758, 10097, 10143, 10267, 10269, 10275, 10427, 10436, 10521, 10545, 10579, 10622, 90097, 90218, 95203, 95319, 95328, 95362, 95369, 95391, 95414, 95427, 95433, 95471, 95486, 95544, 95586, 95604, 95605, 95617, 95628, 95632, 95640, 95672, 95752, 95754 & 95757.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1649-2015

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Class I - Dangerous

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