medical Class II Updated 2020-07-29

Mevion Medical Systems, Inc. recalls MEVION S250 Proton Radiation Treatment System; intended to d

Recalled Product

MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients


Hazard / Issue

The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.

Issued by

FDA

Affected States: MO, NJ, OK, FL, OH, DC
Lot/Code Info: Lot #s: 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
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