FDA Enforcement
Class II
Terminated
MEVION S250 Product Usage: Proton Radiation Therapy System
Recall: Z-0410-2017
·
Reported November 23, 2016
Enforcement
- Recall Number
- Z-0410-2017
- Event ID
- 75498
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Mevion Medical Systems, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 23, 2016
- Initiation Date
- October 21, 2016
- Classification Date
- November 14, 2016
- Termination Date
- May 10, 2017
- Address
- 300 Foster Street, N/A, Littleton, MA, 01460-2017, United States
Description
MEVION S250 Product Usage: Proton Radiation Therapy System
Reason
Recovery of Incorrect Isocenter -operational change
Code Info
Serial Number: S250-0001 through S250-0006
Distribution
US Nationwide Distribution in the states of FL, MO, NJ, OH and OK,
Quantity
6 units