FDA Recall
Terminated
MEVION S250 Radiation therapy system
Recall: Z-0767-2016
·
Initiated November 18, 2015
Recall
- Recall Number
- Z-0767-2016
- Event Number
- 72210
- Firm
- Mevion Medical Systems, Inc.
- FEI Number
- 3007087027
- Product Code
- LHN
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- November 18, 2015
- Posted
- February 8, 2016
- Terminated
- April 3, 2017
- Address
- 300 Foster Street, Littleton, MA, 01460-2017
Description
MEVION S250 Radiation therapy system
Reason
The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
Action
Customer notification letter was sent via certified mail on November 18, 2015. The notification explains the issue and actions to be taken by the customer.
Distribution
US nationwide distribution including FL, NJ, OK, and MO.
Quantity
4