Mevion Proton Radiation Treatment System Recalled for Software Error
Mevion Medical Systems is recalling eight MEVION S250i and S250 Proton Radiation Treatment Systems because a software error can cause couch correction moves to be partially lost.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Mevion Medical Systems, Inc. is recalling eight units of the MEVION S250i and MEVION S250 Proton Radiation Treatment Systems. The recall was initiated due to a software defect affecting the device's positioning capabilities.
The specific issue involves the Couch Correction feature. If a previous correction was sent or recorded with some of the Couch Correction checkboxes turned off, subsequent correction moves sent after using a 3D CT scan may be partially lost. This error could impact the precision of the treatment delivery.
The affected units were distributed to facilities in Missouri, New Jersey, Ohio, Oklahoma, Florida, the District of Columbia, and the Netherlands. Specific serial numbers and UDI codes for the eight units are listed in the official recall documentation. Users of these systems should contact Mevion Medical Systems for instructions on how to resolve the software issue.
The recalled product
- Product
- MEVION S250i, MEVION S250; Proton Radiation Treatment System
- Manufacturer
- Mevion Medical Systems, Inc.
- Affected units
- 8
Distribution
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