Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ingenuity Core Recalled by Philips Medical Systems (Cleveland) Inc Due to After upgrading to 3.6.7 software version via FCO72800643,...
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
Ingenuity Core, Model number 728321 Product Usage: 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.
Quantity: 30
Why Was This Recalled?
After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical scans, the planned anatomy can be cut off on the CT images. This issue can occur on gated CT helical reconstruction that is not planned at iso-center (0,0). If the region of interest is not visualized in the images, a CT rescan may be performed.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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