MEVION S250 Proton Radiation Treatment System recallZ-2686-2020 · Mevion Medical Systems, Inc. · initiated Jun 23, 2020
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
The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
FDA root cause category: Device Design
What the company is doing
This screen would not be accessed by normal user (only servicer). Firm is notifying servicing personnel and not consumer/user level. No customer letters/communication sent. Servicer will install edge guard on effected units. Technical Service Bulletin issued to servicer.
Recall details
- Recall number
- Z-2686-2020
- Status
- Terminated
- Initiated by the company
- Jun 23, 2020
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 8 units
- Product code
- LHO
- FDA submissions
- K120676
- Distribution
- MO, NJ, OK, FL, OH, DC, Netherlands
Product description
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Code information (models, lots, serial numbers)
Lot #s: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008 UDI: (01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219
Devices named in this recall
2 devices 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
- 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 16, 2026. Text above is shown as published by the FDA.
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