MEVION S250 Product Usage: Proton Radiation Therapy System
- Company
- Mevion Medical Systems, Inc.
- Recall Initiated
- October 20, 2016
- Posted
- November 15, 2016
- Terminated
- May 15, 2017
- Recall Number
- Z-0411-2017
- Quantity
- 6 units
- Firm Location
- Littleton, MA
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
Distribution
US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK
Lot / Code Info
Serial Numbers: S250-0001 through S250-0006
Root Cause
Software design
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.
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