Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The device is a whole-body CT x-ray system. The acquired Recalled by Philips North America Llc Due to Three software issues affecting incorrect image display, error...
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 North America Llc directly.
Affected Products
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.
Quantity: 330 units
Why Was This Recalled?
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
Where Was This Sold?
This product was distributed to 25 states: AL, AZ, AR, CA, FL, GA, HI, IL, IN, KY, LA, ME, MD, MI, MS, NJ, NM, NY, NC, OH, OK, PA, RI, TN, TX
About Philips North America Llc
Philips North America Llc has 301 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report