FDA Enforcement
Class II
Terminated
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Recall: Z-2686-2020
·
Reported July 29, 2020
Enforcement
- Recall Number
- Z-2686-2020
- Event ID
- 86028
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Mevion Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Other
- Report Date
- July 29, 2020
- Initiation Date
- June 23, 2020
- Classification Date
- July 22, 2020
- Termination Date
- December 9, 2020
- Address
- 300 Foster St, N/A, Littleton, MA, 01460-2017, United States
Description
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Reason
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.
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
Distribution
MO, NJ, OK, FL, OH, DC, Netherlands
Quantity
8 units