Mevion S250 recall: Software Issue
MEVION S250, used for proton radiation therapy.
Why was Mevion S250 recalled?
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Number: S250-0001
- Product
- MEVION S250, used for proton radiation therapy.
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 1
- Distribution
- US Distribution in the state of MO
- Recall date
- December 17, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)