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Recall Observatory FDA recall evidence

Device product

MEVION S250 Product Usage: Proton Radiation Therapy System

Z-0411-2017

October 20, 2016

Class II

Product summary

Firm
Mevion Medical Systems, Inc.
Event
Event 75494
Status
Terminated
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0411-2017

Official wording

Reason: Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter

Code information: Serial Numbers: S250-0001 through S250-0006

Distribution pattern: US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software defect:2D projection of contours in Verity. The defect