Mevion S250 Proton Therapy System Recalled for Gantry Motion Hazard
Mevion Medical Systems is recalling five MEVION S250 proton therapy systems because an aperture may fall out during gantry motion, posing a risk of traumatic injury or death to patients.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that the hazard can cause 'traumatic injury or death,' which meets the rubric criteria for a Critical (5) severity score due to the potential for fatalities.
Plain-English summary
Mevion Medical Systems, Inc. is recalling five MEVION S250 for Proton Radiation Therapy systems. The recall is due to a possibility of gantry motion occurring when an aperture or compensator is only partially inserted.
The hazard involves the potential for an aperture to fall out during gantry motion. If this occurs, the falling component can hit a patient, causing traumatic injury or death.
The affected units were distributed nationwide to Missouri, Oklahoma, Florida, and New Jersey. The specific code for the affected units is S250-0002. Consumers and healthcare facilities should contact Mevion Medical Systems for instructions on how to address this safety issue.
The recalled product
- Product
- MEVION S250 for Proton Radiation Therapy
- Manufacturer
- Mevion Medical Systems, Inc.
- Affected units
- 5
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)
- S250-0002
Distribution
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