Z-2686-2020Class II

MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

Name: Z-2686-2020 MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Creator: Mevion Medical Systems, Inc.
Published: 2020-06-23
License: https://open.fda.gov/license/

Mevion Medical Systems, Inc. / initiated 2020-06-23 / Terminated / root cause: design

FDA source

Mevion Medical Systems, Inc. began a recall of MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients on 2020-06-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2686-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-23
Posted: 2020-07-22
Terminated: 2020-12-09
Recalling firm: Mevion Medical Systems, Inc.
Product: MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Product code: LHO Instrument, Quality-Assurance, Radiologic
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: This screen would not be accessed by normal user (only servicer). Firm is notifying servicing personnel and not consumer/user level. No customer letters/communication sent. Servicer will install edge guard on effected units. Technical Service Bulletin issued to servicer.
Quantity in commerce: 8 units
Distribution: MO, NJ, OK, FL, OH, DC, Netherlands
Product codes and lots: Lot #s: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008 UDI: (01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2686-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2686-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-29	2020-07-22

Product code LHO

K120676Class IIS-250 Proton Beam Radiation Therapy SystemMevion Medical Systems / cleared 2012-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)