MEVION S250, used for proton radiation therapy recallZ-0588-2015 · Mevion Medical Systems, Inc. · initiated Nov 10, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mevion Medical Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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%.
FDA root cause category: Software design
What the company is doing
Mevion Medical Systems sent an Important Safety Notice letter to the affected customer. The letter identified the affected product, problem and actions to be taken. A software update addressing the issue will be provided to the customer on or about December 5, 2014. For questions or concerns, email [email protected] or call 978-540-1555.
Recall details
- Recall number
- Z-0588-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 10, 2014
- Posted by the FDA
- Dec 12, 2014
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 1
- Product code
- LHN
- FDA submissions
- K120676
- Distribution
- US Distribution in the state of MO
Product description
MEVION S250, used for proton radiation therapy.
Code information (models, lots, serial numbers)
Serial Number: S250-0001
Other devices under the same FDA submission
1 device cleared under K120676 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Mevion Medical Systems S250Mevion Medical Systems, Inc. · System, Radiation Therapy, Charged-Particle, Medical4 recalls1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page