RecallDepth

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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