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.
Take action
Contact the company
📍Recalling firmMevion Medical Systems, Inc.300 Foster St · Littleton, MA 01460-2017
“Mevion S250/Proton Beam System Recall: Unauthorized Couch Tops Risk Injury.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70687-mevion-s250-proton-beam-system-recall-unauthorized-couch-tops-risk. Based on FDA recall #Z-2746-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2746-2018%22&limit=1).
The FDA announced on June 29, 2018, that Mevion Medical Systems, Inc. is recalling the MEVION S250 and S250i Proton Beam Radiation therapy systems due to potential patient injury from unauthorized couch top combinations. The agency classified this as a Class II recall.
How to tell if you have it
Brand: Mevion
Product: MEVION S250/MEVION S250i Proton Beam Radiation therapy system
Model numbers: S250-0001 through S250-0006 and S250i-0007
Quantity: 7 units
The hazard
The recall addresses unauthorized combinations of QFix Couch Tops with non-QFix devices, which can damage the kVue One Touch latch mechanism. This damage creates unsafe conditions and may compromise subsequent use of any kVue inserts, potentially leading to incorrect patient treatment or physical injury.
Context
GovInfoNow's records show Mevion Medical Systems, Inc. has issued five other recalls since October 1, 2018. On February 1, 2022, the company recalled the S250 Hand Pendant due to unintentional motion risks, and on October 19, 2020, it recalled the S250i/S250 Proton Therapy System for treatment beam information disappearing. Other recent recalls of similar products include the IBA Proton Therapy System PROTEUS 235 (February 3, 2026), Hitachi Proton Beam Therapy System (February 6, 2026), and GE Maxxus Nuclear Medicine Systems (December 10, 2025).
How to tell if you have this one
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.
Brand
Mevion
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Couch Top Compatibility
Verify if your QFix couch top is officially validated for your Mevion S250 or S250i system.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of DC, FL, MO, NJ, OH, and OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: District of Columbia, Florida, Missouri, New Jersey, Ohio, Oklahoma.
Recall timeline
FDA terminated this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2746-2018 (June 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2746-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.