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U.S. Department of Health and Human Services

Class 2 Device Recall MEVION

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 Class 2 Recall
MEVION
see related information
Date Posted March 22, 2014
Recall Status1 Terminated on April 03, 2014
Recall Number Z-1271-2014
Recall Event ID 67657
Premarket Notification
510(K) Number
K120676 
Product Classification System, Radiation Therapy, Charged-Particle, Medical - Product Code LHN
Product MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Code Information S250-0001
Recalling Firm/
Manufacturer
Mevion Medical Systems, Inc.
300 Foster St
Littleton, Massachusetts 01460-2017
For Additional Information Contact Robyn Kressin
978-540-1500
Manufacturer Reason
for Recall
Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
FDA Determined
Cause 2
DESIGN: Software Design
Action Mervion issued an Important Safety Notice letter on March 5, 2014 by visit to sites to the single customer using the product to prevent the use of multiple isocenters treatment modalities. The letter identified the affected product, problem and actions to be taken. For questions call 978-540-1555.
Quantity in Commerce 1 unit
Distribution USA Nationwide Distribution in the state of MO
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LHN and Original Applicant = MEVION MEDICAL SYSTEMS
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