Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Recalled by Philips Medical Systems (Cleveland) Inc Due to A head holder released for use with other...
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
Head Holder shipped with Ingenuity Core 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: 79 units
Why Was This Recalled?
A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core, which was shipped with this system.
Where Was This Sold?
This product was distributed to 32 states: AZ, AR, CA, CO, CT, FL, GA, IN, IA, KS, LA, MD, MA, MI, MS, MO, NV, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, VT, VA, WA, WV, WY
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