Mevion S250 Proton Therapy System Recalled for Software Defect
Mevion Medical Systems is recalling one MEVION S250 proton therapy system in Missouri due to a software defect that may cause incorrect dose delivery.
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 could lead to incorrect radiation dose delivery, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Mevion Medical Systems, Inc. is recalling one MEVION S250 proton radiation therapy system (Serial Number: S250-0001) distributed in the state of Missouri. The recall is due to a software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either the pressure or temperature sensor malfunctions.
This defect could result in an incorrect dose delivery of no more than 5%. The source text does not report any injuries or illnesses associated with this recall.
Healthcare facilities that have this specific unit should contact Mevion Medical Systems, Inc. for further instructions on how to address the software defect.
The recalled product
- Product
- MEVION S250, used for proton radiation therapy.
- Manufacturer
- Mevion Medical Systems, Inc.
- Affected units
- 1
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 Number: S250-0001
Distribution
Distributed in 1 state:
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