MEVION S250 Product Usage: Proton Radiation Therapy System
FDA device recall Z-0410-2017 · posted 2016-11-15 · Terminated
Recall details
- Recalling firm
- Mevion Medical Systems, Inc.
- Reason for recall
- Recovery of Incorrect Isocenter -operational change
- Action taken
- Mevion issued an User Notice letter on October 24, 2016 to their customers. The letter identified the affected product, problem and actions taken. Customers were informed that Mevion will be updating software when it is released. For further clarification or assistance, please contact Rob Cessac by email at rcessac@mevion.com or by phone at (978) 540-1501.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 6 units
- Distribution
- US Nationwide Distribution in the states of FL, MO, NJ, OH and OK,
- Date initiated
- 2016-10-21
- Date posted
- 2016-11-15
- Date terminated
- 2017-05-10
- Location
- Littleton, MA
Monitor recalls programmatically
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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 |