MEVION S250 Product Usage: Proton Radiation Therapy System
- Company
- Mevion Medical Systems, Inc.
- Recall Initiated
- October 21, 2016
- Posted
- November 15, 2016
- Terminated
- May 10, 2017
- Recall Number
- Z-0410-2017
- Quantity
- 6 units
- Firm Location
- Littleton, MA
Reason for Recall
Recovery of Incorrect Isocenter -operational change
Distribution
US Nationwide Distribution in the states of FL, MO, NJ, OH and OK,
Lot / Code Info
Serial Number: S250-0001 through S250-0006
Root Cause
Software Design 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.
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