MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proto
FDA device recall Z-1271-2014 · posted 2014-03-22 · Terminated
Recall details
- Recalling firm
- Mevion Medical Systems, Inc.
- Reason for recall
- Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- LHN
- Quantity affected
- 1 unit
- Distribution
- USA Nationwide Distribution in the state of MO
- Date initiated
- 2014-03-05
- Date posted
- 2014-03-22
- Date terminated
- 2014-04-03
- Location
- Littleton, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| S-250 PROTON BEAM RADIATION THERAPY SYSTEM (K120676) | Mevion Medical Systems | 2012-06-04 |