High FDA (Devices)·Z-0485-2021·Announced 2020-12-02

Mevion Proton Radiation Treatment System Recalled for Screen Display Failure

Mevion Medical Systems is recalling eight MEVION S250 and S250i proton radiation treatment systems because treatment beam information may disappear from the console screen while the beam continues to deliver.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that creates a 'potential for harm to a patient' during active treatment, but the source text does not report any actual injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Mevion Medical Systems, Inc. is recalling eight units of the MEVION S250 and MEVION S250i Proton Radiation Treatment Systems. These devices are intended to deliver proton radiation treatment to patients with localized tumors or other conditions susceptible to radiation therapy.

The recall is due to a defect where treatment beam information disappears on the Treatment Console screen while beam delivery continues. This display failure creates a potential for harm to a patient, as operators may not have accurate visual confirmation of the beam status during treatment.

The affected units were distributed worldwide, including nationwide in the United States (specifically in DC, FL, MO, NJ, and OK) and in the Netherlands. The recall includes specific serial numbers and UDI codes for the eight affected units. Users of these devices should contact Mevion Medical Systems for further instructions on how to address the issue.

The recalled product

Product: 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
Manufacturer: Mevion Medical Systems, Inc.
Category: Medical Device — Radiation Therapy Equipment
Hazard: display-failure
patient-harm
Affected units: 8

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Mevion Medical Systems, Inc.

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Mevion S250 Proton Radiation System Recalled for Sharp Edge Hazard
FDA (Devices) · 2020-07-29
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Mevion Proton Radiation Treatment System Recalled for Software Error
FDA (Devices) · 2020-07-01
Moderate
Mevion Medical Systems Recalls MEVION S250i Medical Device
FDA (Devices) · 2019-01-16
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Mevion Medical Systems Recalls MEVION S250 Proton Beam Therapy Systems
FDA (Devices) · 2018-08-22

Same hazard · display failure