Feb

2017

Cl II MEVION S250-Proton Radiation Therapy

Company: Mevion Medical Systems, Inc..
Date of Enforcement Report 2/8/2017
Class lI:

PRODUCT

MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Recall Number Z-1122-2017

REASON
An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened

RECALLING FIRM/MANUFACTURER
Mevion Medical Systems, Inc., Littleton, MA on 12/16/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2 units

DISTRIBUTION
US Nationwide in the states of OK, NJ

___________________________________

About the author

Amy Sellers

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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Cl II MEVION S250-Proton Radiation Therapy

Amy Sellers

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