Mevion S250 recallZ-0411-2017 · Mevion Medical Systems, Inc. · initiated Oct 20, 2016
Class II Terminated All recalls posted in November 2016
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:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter
FDA root cause category: Software design
What the company is doing
Mevion issued an Important Safety Notice letter on October 14, 2016 to their customers. The letter identified the affected product, problem, containment, mitigation and actions taken. Customers were informed that Mevion will be updating software when it is released. For further Information, contact: [email protected].
Recall details
- Recall number
- Z-0411-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 20, 2016
- Posted by the FDA
- Nov 15, 2016
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 6 units
- Product code
- MUJ
- FDA submissions
- K120676
- Distribution
- US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK
Product description
MEVION S250 Product Usage: Proton Radiation Therapy System
Code information (models, lots, serial numbers)
Serial Numbers: S250-0001 through S250-0006
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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