MEVION S250 Product Usage: Proton Radiation Therapy
- Company
- Mevion Medical Systems, Inc.
- Recall Initiated
- October 31, 2016
- Posted
- November 15, 2016
- Terminated
- June 29, 2017
- Recall Number
- Z-0409-2017
- Quantity
- 6 units
- Firm Location
- Littleton, MA
Reason for Recall
Completing Setup Without Program Move Complete Can Cause An Isocenter Error
Distribution
US Nationwide in the states of FL, MO, NJ and 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 31, 2016 to customers. The identified the affected product, problem, mitigation and advisory information. The letter informed customers that Mevion will release and install a software patch that removes the reliance on tracking isocenter changes for the correct reporting of the Couch position to the user displays and to the OIS. For further information mailto:srosenthal@mevion.com
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