MEVION S250 Radiation therapy system recallZ-0767-2016 · Mevion Medical Systems, Inc. · initiated Nov 18, 2015
Class II Terminated All recalls posted in February 2016
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
The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
FDA root cause category: Labeling design
What the company is doing
Customer notification letter was sent via certified mail on November 18, 2015. The notification explains the issue and actions to be taken by the customer.
Recall details
- Recall number
- Z-0767-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 18, 2015
- Posted by the FDA
- Feb 8, 2016
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 4
- Product code
- LHN
- FDA submissions
- K120676
- Distribution
- US nationwide distribution including FL, NJ, OK, and MO.
Product description
MEVION S250 Radiation therapy system
Code information (models, lots, serial numbers)
Manufacturing Lot or Serial Number: S250-0004
Other devices under the same FDA submission
1 device cleared under K120676 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Mevion Medical Systems S250Mevion Medical Systems, Inc. · System, Radiation Therapy, Charged-Particle, Medical4 recalls1 report
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 18, 2026. Text above is shown as published by the FDA.
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