RecallDepth

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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