MEVION S250, System, Radiation Therapy, Charged-Particle… recallZ-1271-2014 · Mevion Medical Systems, Inc. · initiated Mar 5, 2014
Class II Terminated All recalls posted in March 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
Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
FDA root cause category: Software design
What the company is doing
Mervion issued an Important Safety Notice letter on March 5, 2014 by visit to sites to the single customer using the product to prevent the use of multiple isocenters treatment modalities. The letter identified the affected product, problem and actions to be taken. For questions call 978-540-1555.
Recall details
- Recall number
- Z-1271-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 5, 2014
- Posted by the FDA
- Mar 22, 2014
- Recalling firm
- Mevion Medical Systems, Inc.
- Quantity
- 1 unit
- Product code
- LHN
- FDA submissions
- K120676
- Distribution
- USA Nationwide Distribution in the state of MO
Product description
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Code information (models, lots, serial numbers)
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