Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Recalled by Philips Medical Systems (Cleveland) Inc Due to Philips is issuing a software update (version 3.2.4)...
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 iCT and iCT SP are 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 analysis and display equipment, patient, and equipment supports, components and accessories. The Brilliance iCT and iCT SP are used to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Quantity: 241
Why Was This Recalled?
Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest sc
Where Was This Sold?
This product was distributed to 22 states: AL, CA, DE, FL, GA, IN, IA, MD, MA, MN, MS, NY, NC, OH, OR, PA, TN, TX, VT, WA, WV, DC
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