Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brilliance iCT Intended to produce images of the head and Recalled by Philips Medical Systems (Cleveland) Inc Due to Philips has identified that certain fasteners cannot be...
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 iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Quantity: 13
Why Was This Recalled?
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Where Was This Sold?
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
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