Dec

2014

Cl II MEVION S250

Company: Mevion Medical Systems, Inc..
Date of Enforcement Report 12/17/2014
Class lI:

PRODUCT

MEVION S250, used for proton radiation therapy.
Recall Number Z-0588-2015

REASON
Software defect that causes an incorrect dose compensation function to be applied to the internal dose ionization chamber when either pressure or temperature sensor malfunction. This could result in an incorrect dose delivery of no more than 5%.

RECALLING FIRM/MANUFACTURER
Mevion Medical Systems, Inc., Littleton, MA 11/10/2014. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
US Distribution in the state of MO

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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

Amy Sellers

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