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U.S. Department of Health and Human Services

Enforcement Report - Week of April 2, 2014

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Product Detail

Product Description MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Recall Number Z-1271-2014
Classification Class II
Code Info S250-0001
Product Distributed Qty 1 unit
Reason For Recall Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields

Event Detail

Event Id 67657
Product Type Devices
Status Ongoing
Recalling Firm Mevion Medical Systems, Inc.
City Littleton
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-05
Initial Firm Notification of Consignee or Public Visit
Distribution Pattern USA Nationwide Distribution in the state of MO