Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Brilliance 64 and Ingenuity CT are whole body Computed Recalled by Philips Medical Systems (Cleveland) Inc Due to 1. The current system design of software version...
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
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: 8
Why Was This Recalled?
1. The current system design of software version 4.0.0xx379 does not prevent the system from scanning if the dose level exceeds a set upper dose limit for CT Brain Perfusion scanning, which previous versions did. However, the current version does have the Dose Check (NEMA XR-25) feature, which provides dose notifications and alerts, but it is possible for the user to disable Dose Check after ente
Where Was This Sold?
This product was distributed to 2 states: IN, OH
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