Mevion Medical Systems Recalls MEVION S250i Medical Device
Mevion Medical Systems is recalling one MEVION S250i unit due to a dDose1 interlock trip. Treatment may continue via partials.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any injuries, illnesses, or deaths, and the hazard appears to be a functional interlock issue rather than a direct physical danger, fitting the criteria for a moderate severity voluntary precautionary or functional recall.
Plain-English summary
Mevion Medical Systems, Inc. is recalling one unit of the MEVION S250i medical device. The recall is identified by recall number Z-0705-2019 and involves a specific unit with Serial Number S250i-0007.
The recall was initiated because the dDose1 interlock has tripped. According to the source text, treatment is allowed to continue via partials in situations where this interlock has tripped.
The affected unit is distributed in the District of Columbia (DC). No specific consumer instructions beyond the note regarding treatment continuation are provided in the source text.
The recalled product
- Product
- MEVION S250i
- Manufacturer
- Mevion Medical Systems, Inc.
- Hazard
- 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)
- DI: (01)00864366000124 Serial Number: S250i-0007
Distribution
Distributed in 1 state:
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