Mevion Medical Systems, Inc. MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Brand
Mevion Medical Systems, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Mevion Medical Systems, Inc. is recalling MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to pat due to 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 potentia. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, MO, NJ, OH, OK, DC
Page updated: Jan 10, 2026