MEVION S250 Cl II

Company: Mevion Medical Systems, Inc.
Date of Enforcement Report 11/23/2016
Class lI:

PRODUCT

MEVION S250 Product Usage: Proton Radiation Therapy System
Recall Number Z-0411-2017

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.

RECALLING FIRM/MANUFACTURER
Mevion Medical Systems, Inc., Littleton, MA on 11/14/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6

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

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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