MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
- Company
- Mevion Medical Systems, Inc.
- Recall Initiated
- December 16, 2016
- Posted
- February 2, 2017
- Terminated
- April 13, 2017
- Recall Number
- Z-1122-2017
- Quantity
- 2 units
- Firm Location
- Littleton, MA
Reason for Recall
An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
Distribution
US Nationwide in the states of OK, NJ
Lot / Code Info
S250-0002 and S250-0003
Root Cause
Software design
Action Taken
Mevion sent an Important Safety Notice to customers on 12/16/16 by email and Salesforce. The letter identified the affected product, problem and actions to be taken. Mevion provided mitigation and will release and install a software patch that removes the possibility that Deltas can be lost between multiple Setup fields. For further information contact rcessac@mevion.com.
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