MEVION S250i, MEVION S250 recallZ-0485-2021 · Mevion Medical Systems, Inc. · initiated Oct 19, 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
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
FDA root cause category: Device Design
What the company is doing
Mevion issued User Notice by mail or FedEx, with return receipt confirmation on October 22, 2020. The letter states reason for recall, health risk and action to take: The User should actively monitor the TC screen during beam delivery. In the event the TC screen beam information appears blank during Beam On, the user should: Immediately suspend treatment by selecting Beam Off on the Beam Control Box. Record the MU counts displayed on the HMUC before any other action is taken. Consult physics to make manual adjustments of the plan. Notify Field Service to retrieve machine records of the partial beam delivery. Resumption of treatment requires Setup workflow to be repeated. Corrective Action All users should be notified of this scenario and the proper response. Please contact Mevion Customer service with any questions or concerns. Please distribute this notice to all users of the Mevion Medical Systems device at your organization who may be affected by this issue User confirmation of receipt shall also be received from each affected customer site. Customer Service Engineers are also permanently in working residence at customer sites and will ensure awareness of the issue.
Recall details
- Recall number
- Z-0485-2021
- Status
- Terminated
- Initiated by the company
- Oct 19, 2020
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 8 units
- Product code
- LHN
- FDA submissions
- K172848
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands.
Product description
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
Code information (models, lots, serial numbers)
Serial Numbers: 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.
How recalls are matched to devices · Editorial policy · Report an error on this page