medical Class II Updated 2020-07-01

Mevion Medical Systems, Inc. recalls MEVION S250i, MEVION S250; Proton Radiation Treatment System

Recalled Product

MEVION S250i, MEVION S250; Proton Radiation Treatment System


Hazard / Issue

Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off

Issued by

FDA

Affected States: MO, NJ, OH, OK, FL, DC
Lot/Code Info: Serial Numbers: MEVION S250-0001 MEVION S250-0002 MEVION S250-0003 MEVION S250-0004 MEVION S250-0005 MEVION S250-0006 MEVION S250-0007 MEVION S250-0008 UDI: (01)00864366000100 (11) 131209 (01)00864366000100 (11)150526 (01)00864366000100 (11)150113 (01)00864366000100 (11)150430 (01)00864366000100 (11)160127 (01)00864366000100 (11)160603 (01)00864366000124 (11) 180220 (01)00864366000124 (11) 181219
View official government recall

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