🔍 RecallPedia

Brilliance iCT 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 analysts and display equipment, patient and equipment supports, components, and accessories

Class I - Dangerous
🏥 Medical Devices Recalled: November 25, 2016 Philips Medical Systems (Cleveland) Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26
  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:
Failure to correctly document the installation of four M12 Bolts into the system rotor.
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 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 analysts and display equipment, patient and equipment supports, components, and accessories

Product Codes/Lot Numbers:

Model Number 728306; System Serial Number 100619 Rorot-45535-673-94382 SN26

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1004-2017

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Philips Medical Systems (Cleveland)

Class I - Dangerous

Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.

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