Mevion S250 Proton Radiation Therapy System Recalled for Positioning Error
Mevion Medical Systems is recalling the S250 Proton Radiation Therapy System because a geometric positioning error can occur after rotational corrections are applied to treatment fields.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that could lead to incorrect treatment delivery (risk of harm), but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Mevion Medical Systems, Inc. is recalling the MEVION S250 System, a charged-particle medical device used for Proton Radiation Therapy. The recall involves 1 unit of the system.
The recall is being issued because a geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields. This issue could affect the accuracy of the radiation therapy delivered to patients.
The affected unit was distributed nationwide in the United States, specifically within the state of Missouri. The specific unit code is S250-0001. Users of this device should contact Mevion Medical Systems, Inc. for further instructions on how to address the positioning error.
The recalled product
- Product
- MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- Manufacturer
- Mevion Medical Systems, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- S250-0001
Distribution
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