Device product

MEVION S250i, MEVION S250; Proton Radiation Treatment System

Z-2406-2020

May 15, 2020

Class II

Product summary

Firm: Mevion Medical Systems, Inc.
Event: Event 85748
Status: Terminated
Classification: Class II
Quantity: 8 units
Official record key: device-enforcement:Z-2406-2020

Official wording

Reason: 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

Code information: 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

Distribution pattern: Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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