MEVION S250 Product Usage: Proton Radiation Therapy System
FDA device recall Z-0411-2017 · posted 2016-11-15 · Terminated
Recall details
- Recalling firm
- Mevion Medical Systems, Inc.
- Reason for recall
- 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
- Action taken
- 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: srosenthal@mevion.com.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 6 units
- Distribution
- US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK
- Date initiated
- 2016-10-20
- Date posted
- 2016-11-15
- Date terminated
- 2017-05-15
- Location
- Littleton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| S-250 PROTON BEAM RADIATION THERAPY SYSTEM (K120676) | Mevion Medical Systems | 2012-06-04 |