Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Philips Healthcare Ingenuity CT X-Ray Recalled by Philips Electronics North America Corporation Due to During a bolus tracking procedure, no images were...
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 Electronics North America Corporation directly.
Affected Products
Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Quantity: US - 606
Why Was This Recalled?
During a bolus tracking procedure, no images were generated when the scan was completed, and the raw data file was not available for offline reconstruction. There is a discrepancy between the calculated reconstruction length and the actual scan length that results in the inability to reconstruct raw data. The operator may choose to rescan the patient.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Philips Electronics North America Corporation
Philips Electronics North America Corporation has 160 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report