🔍 RecallPedia

Brilliance iCT Computed Tomography X-ray system

Class I - Dangerous
🏥 Medical Devices Recalled: October 29, 2015 Philips Medical Systems (Cleveland) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model No. 728306; S/N: 85015, 85021, 85028, 85034, 85036, 85039, 85042, 85047, 85051, 100030, 100038, 100040, 100051, 100054, 100058, 100065, 100072, 100093, 100094, 100099, 100101, 100140, 100144, 100162, 100181, 100190, 100214, 100217, 100228, 100236, 100244, 100278, 100421, 100462, 100472, 100613, 100616, 100624, 100627, 100628, 100632, 100639, 100640, 100641, 100644, 100647, 100651, 100654, 100655, 100659, 100660, 100662, 100667 & 100669.
  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:
Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Brilliance iCT Computed Tomography X-ray system

Product Codes/Lot Numbers:

Model No. 728306; S/N: 85015, 85021, 85028, 85034, 85036, 85039, 85042, 85047, 85051, 100030, 100038, 100040, 100051, 100054, 100058, 100065, 100072, 100093, 100094, 100099, 100101, 100140, 100144, 100162, 100181, 100190, 100214, 100217, 100228, 100236, 100244, 100278, 100421, 100462, 100472, 100613, 100616, 100624, 100627, 100628, 100632, 100639, 100640, 100641, 100644, 100647, 100651, 100654, 100655, 100659, 100660, 100662, 100667 & 100669.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0545-2016

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