MEVION S250-Proton Radiation Therapy recallZ-1122-2017 · Mevion Medical Systems, Inc. · initiated Dec 16, 2016
Class II Terminated All recalls posted in February 2017
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
An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
FDA root cause category: Software design
What the company is doing
Mevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact [email protected].
Recall details
- Recall number
- Z-1122-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 16, 2016
- Posted by the FDA
- Feb 2, 2017
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 2 units
- Product code
- LHN
- FDA submissions
- K120676
- Distribution
- US Nationwide in the states of OK, NJ
Product description
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Code information (models, lots, serial numbers)
S250-0002 and S250-0003
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.
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