MEVION S250 Product Usage: Proton Radiation Therapy
FDA Recall Z-0409-2017 · Posted 2016-11-15
Recalling FirmMevion Medical Systems, Inc.
Recall StatusTerminated
Product CodeMUJ
Date Initiated2016-10-31
Date Terminated2017-06-29
Product Quantity6 units
Reason for Recall
Completing Setup Without Program Move Complete Can Cause An Isocenter Error
Firm Action
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:[email protected]
Root Cause
Software design
Distribution Pattern
US Nationwide in the states of FL, MO, NJ and OK
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.