Mevion S250 Proton Radiation System Recalled for Sharp Edge Hazard
Mevion Medical Systems is recalling eight MEVION S250 Proton Radiation Treatment Systems because a sharp edge on a perforated screen poses an injury risk to service personnel.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm product (sharp edge injury) where no specific injuries have been reported yet, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Mevion Medical Systems, Inc. is recalling eight units of the MEVION S250 Proton Radiation Treatment System. The recall is due to a defect in the process water tank where a perforated screen has a very sharp edge across the top of the Heat Exchanger.
This sharp edge creates a potential injury risk for service personnel who work on the equipment. The affected units are distributed in Missouri, New Jersey, Oklahoma, Florida, Ohio, the District of Columbia, and the Netherlands.
Service providers and facilities using these systems should contact Mevion Medical Systems for instructions on how to address the defect. The recall number is Z-2686-2020.
The recalled product
- Product
- MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
- Manufacturer
- Mevion Medical Systems, Inc.
- Hazard
- Affected units
- 8
Distribution
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