MEVION S250i recallZ-0705-2019 · Mevion Medical Systems, Inc. · initiated Oct 1, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mevion Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
On-site Mevion Field Service Engineer communicated with the firm and is in daily communication with the single affected consignee.
Recall details
- Recall number
- Z-0705-2019
- Status
- Terminated
- Initiated by the company
- Oct 1, 2018
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 1 unit
- Product code
- LHN
- FDA submissions
- K172848
- Distribution
- DC
Product description
MEVION S250i
Code information (models, lots, serial numbers)
DI: (01)00864366000124 Serial Number: S250i-0007
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MEVION S250iMevion Medical Systems, Inc. · System, Radiation Therapy, Charged-Particle, Medical5 recalls5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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