Mevion S250 Proton Therapy Units Recalled for Data Loss Error
Mevion Medical Systems is recalling two S250 Proton Radiation Therapy units because a software error can cause Delta corrections to be lost.
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 high-risk medical device where a software error could compromise treatment accuracy, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Mevion Medical Systems, Inc. is recalling two units of the MEVION S250 Proton Radiation Therapy system. The affected units are identified by serial numbers S250-0002 and S250-0003. These devices were distributed in the United States, specifically in the states of Oklahoma and New Jersey.
The recall is due to a software error that can cause Delta corrections to be lost when one setup field is closed and another is opened. This issue affects the integrity of the data used during the proton radiation therapy process.
Healthcare facilities that have these specific units should contact Mevion Medical Systems for further instructions on how to address the error. Patients who have received treatment on these units should consult with their medical providers regarding the potential impact of the data loss.
The recalled product
- Product
- MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- Manufacturer
- Mevion Medical Systems, Inc.
- Hazard
- Affected units
- 2
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 and S250-0003
Distribution
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