The Recall Desk
HighFDA (Devices)·Z-0409-2017·Announced 2016-11-23

Mevion S250 Proton Therapy Systems Recalled for Isocenter Error Risk

Mevion Medical Systems is recalling six MEVION S250 proton radiation therapy units because completing setup without a program move can cause an isocenter error.

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 potential for significant harm (isocenter error in radiation therapy) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Mevion Medical Systems, Inc. is recalling six MEVION S250 proton radiation therapy systems. The recall was initiated because completing the setup process without executing a program move can result in an isocenter error.

The affected units are identified by serial numbers S250-0001 through S250-0006. These devices were distributed nationwide in the states of Florida, Missouri, New Jersey, and Oklahoma.

Healthcare facilities using these systems should contact Mevion Medical Systems for further instructions on how to address the potential setup error.

The recalled product

Product
MEVION S250 Product Usage: Proton Radiation Therapy
Manufacturer
Mevion Medical Systems, Inc.
Category
Medical Device — Radiation Therapy
Hazard
Affected units
6

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial NUmbers: S250-0001 through S250-0006

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Related recalls

Same manufacturer · Mevion Medical Systems, Inc.

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