Mevion recalls S250/Proton Beam systems with unauthorized QFix couch tops that may cause incorrect treatment or injury during radiation therapy.
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.
Mevion is recalling S250 and S250i proton beam radiation therapy systems that have unauthorized QFix couch tops. Using these incompatible parts could lead to incorrect patient treatment or physical injury during radiation therapy.
The kVue Oen Touch latch can be damaged when used with third-party accessories. This may cause incorrect patient treatment or physical injury during radiation therapy sessions.
Healthcare facilities using Mevion S250 or S250i systems with unauthorized QFix couch tops are affected. Patients receiving radiation therapy with these systems are at risk of incorrect treatment or injury.
Check if your Mevion S250 or S250i system has QFix couch tops that aren't officially validated. The affected models are S250-0001 through S250-0006 and S250i-0007.
Verify if your QFix couch top is officially validated for your Mevion S250 or S250i system.
Unauthorized QFix couch tops can damage the kVue Oen Touch latch, leading to incorrect patient treatment or physical injury during radiation therapy.
S250-0001 through S250-0006 and S250i-0007 models.
Check if your QFix couch top is officially validated for your Mevion system. If not, contact Mevion for guidance.
We’ve drafted a message you can send Mevion to request your refund or repair — edit it as you like.
Subject: Recall Z-2746-2018 — Mevion Mevion Hello, I own a Mevion that is covered by recall Z-2746-2018 from Mevion. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
