FDA Recall
Terminated
MEVION S250 Product Usage: Proton Radiation Therapy System
Recall: Z-0411-2017
·
Initiated October 20, 2016
Recall
- Recall Number
- Z-0411-2017
- Event Number
- 75494
- Firm
- Mevion Medical Systems, Inc.
- FEI Number
- 3007087027
- Product Code
- MUJ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- October 20, 2016
- Posted
- November 15, 2016
- Terminated
- May 15, 2017
- Address
- 300 Foster Street, Littleton, MA, 01460-2017
Description
MEVION S250 Product Usage: Proton Radiation Therapy System
Reason
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
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].
Distribution
US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK
Quantity
6 units