Use cautionMedical device recall · FDA · Published June 23, 2020
Mevion S250 Proton Therapy System Recall: Sharp Screen Risk for Servicers
Mevion recalls S250 proton radiation treatment systems with a sharp screen edge that could injure service technicians during maintenance. Affected units have specific lot numbers and UDI codes.
The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
Take action
Contact the company
📍Recalling firmMevion Medical Systems, Inc.300 Foster St · Littleton, MA 01460-2017
✎ GovInfoNow plain-language explainer
Mevion is recalling its S250 Proton Radiation Treatment System because a perforated screen inside the water tank has a sharp edge that could cause injury to service technicians. This recall affects specific units with listed lot numbers and unique identifiers. Read more at govinfonow.com/recall/64918-mevion-s250-proton-therapy-system-recall-sharp-screen-risk-for.
“Mevion S250 Proton Therapy System Recall: Sharp Screen Risk for Servicers.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64918-mevion-s250-proton-therapy-system-recall-sharp-screen-risk-for. Based on FDA recall #Z-2686-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2686-2020%22&limit=1).
The FDA announced on June 23, 2020, that Mevion Medical Systems, Inc. is recalling the MEVION S250 Proton Radiation Treatment System due to a sharp edge hazard. The agency stated the perforated screen inside the process water tank presents a potential injury risk for service personnel.
How to tell if you have it
Brand: Mevion
Product: MEVION S250 Proton Radiation Treatment System
Lot codes: MEVION S250-0001 through MEVION S250-0008
UPCs: 00864366000100, 00864366000124
The hazard
According to the FDA, the perforated screen dividing the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger. This condition leads to potential injury for servicer.
Context
GovInfoNow's records show Mevion Medical Systems, Inc. has five other recalls on record since June 29, 2018. Other recent recalls of similar products include the IBA Proton Therapy System PROTEUS 235 Recall (Feb. 3, 2026), Hitachi Proton Beam Therapy System Recall (Feb. 6, 2026), and Philips Allura Xper FD10C Medical System Recall (Dec. 15, 2025).
How to tell if you have this one
Check for lot numbers MEVION S250-0001 through MEVION S250-0008. Also look for unique identifiers (UDIs) with specific codes like (01)00864366000100 and (11)131209.
Brand
Mevion
Product
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Recalled Units
Identify if your unit has lot numbers MEVION S250-0001 through MEVION S250-0008 or the listed UDI codes.
Where it went and when
Where it was distributed
Distributed in 5 states and D.C., and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “MO, NJ, OK, FL, OH, DC, Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: District of Columbia, Florida, Missouri, New Jersey, Ohio, Oklahoma.
Recall timeline
FDA terminated this recall 6 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-2686-2020 (June 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2686-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.