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.

On June 29, 2018, the firm sent out a User Notice to consignees to alert customers to the Advisory Notice issued by QFix regarding the use of an Orfit HP Pro Solution combined with the QFix kVue couch top. Customers using third-party inserts are advised to immediately inspect the latching mechanism for damage and contact the third-party insert vendor for advice on the use of the insert and confirmation of compatibility. Mevion will update user manuals to include the following warning about using alternative third party vendor inserts: WARNING: Interchangeable Couch Top inserts are integral to the immobilization, treatment beam planning, and physical safety of each patient. Use of unauthorized or unvalidated inserts may lead to an incorrect patient treatment or physical injury. Only use Mevion-provided accessories or devices that are confirmed by the third party suppliers to be compatible with the Mevion Couch for safe and effective patient treatment. Please contact Rob Cessac at rcessac@mevion.com or call 636-485-4962 for any questions or concerns.