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

___________________________________

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.