Z-2406-2020 Class II Terminated
FDA device recall Z-2406-2020 was initiated by Mevion Medical Systems, Inc. on May 15, 2020 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated December 11, 2020). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2020
- Initiation Date
- May 15, 2020
- Termination Date
- December 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
MEVION S250i, MEVION S250; Proton Radiation Treatment System
Reason for Recall
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
Distribution Pattern
Distribution to US in MO, NJ, OH, OK, FL, and DC, and the Netherlands
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