Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Recalled by Mevion Medical Systems, Inc. Due to QFix has advised Mevion Medical Systems that they...
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 Mevion Medical Systems, Inc. directly.
Affected Products
MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
Quantity: 7
Why Was This Recalled?
QFix has advised Mevion Medical Systems that they are identifying unauthorized combinations of QFix Couch Tops with non-QFix devices in clinical use. The kVue Oen Touch latch consists of a precision latch mechanism that can be damaged when used with incompatible (third-party) accessories. This can create unsafe conditions for use and may compromise the subsequent use of any kVue inserts, whether authorized or not. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mevion Medical Systems, Inc.
Mevion Medical Systems, Inc. has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report