Mevion Medical Systems, Inc. MEVION S250, used for proton radiation therapy. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MEVION S250, used for proton radiation therapy.
Brand
Mevion Medical Systems, Inc.
Lot Codes / Batch Numbers
Serial Number: S250-0001
Products Sold
Serial Number: S250-0001
Mevion Medical Systems, Inc. is recalling MEVION S250, used for proton radiation therapy. due to Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temp. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
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
IN, MO
Page updated: Jan 13, 2026