Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance Recalled by Philips Medical Systems (Cleveland) Inc Due to This field change order is being released to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Philips Medical Systems (Cleveland) Inc directly.
Affected Products
Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body 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. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Quantity: 42 Units
Why Was This Recalled?
This field change order is being released to update software and customer release notes to the affected installed base.
Where Was This Sold?
This product was distributed to 19 states: AZ, AR, IN, KS, LA, MA, MN, MS, MT, NJ, NY, OH, OR, PA, TN, TX, VT, WV, WY
About Philips Medical Systems (Cleveland) Inc
Philips Medical Systems (Cleveland) Inc has 313 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report