Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fx SOLUTIONS CENTERED HEAD CoCr 50x19 Recalled by Fx Solutions Due to Breach in the external blister of certain lots...
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 Fx Solutions directly.
Affected Products
Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Quantity: 131 units
Why Was This Recalled?
Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fx Solutions
Fx Solutions has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report