Mevion S250 Proton Radiation Therapy Systems Recalled for Isocenter Recovery Issue
Mevion Medical Systems is recalling six MEVION S250 Proton Radiation Therapy Systems due to an operational change affecting the recovery of the incorrect isocenter.
What this means for you
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 is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source does not report any injuries or illnesses, placing it in the High severity category per the rubric for risk-of-harm products without reported injury.
Plain-English summary
Mevion Medical Systems, Inc. is recalling six units of the MEVION S250 Proton Radiation Therapy System. The recall is due to an operational change related to the recovery of the incorrect isocenter.
The affected units are identified by serial numbers S250-0001 through S250-0006. These systems were distributed nationwide in the United States, specifically in the states of Florida, Missouri, New Jersey, Ohio, and Oklahoma.
The U.S. Food and Drug Administration has classified this as a Class II recall. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take.
The recalled product
- Product
- MEVION S250 Product Usage: Proton Radiation Therapy System
- Manufacturer
- Mevion Medical Systems, Inc.
- Hazard
- Affected units
- 6
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)
- Serial Number: S250-0001 through S250-0006
Distribution
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