Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems Recalled by Philips Medical Systems (Cleveland) Inc Due to Philips identified a 4D CT pulmonary phase issue...
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 BigBore Radiology CT - 728244 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. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
Quantity: 67
Why Was This Recalled?
Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Where Was This Sold?
This product was distributed to 22 states: AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MA, MI, MO, NE, NJ, NM, NY, NC, OH, TX, WI
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