MEVION S250 Radiation therapy system
- Company
- Mevion Medical Systems, Inc.
- Recall Initiated
- November 18, 2015
- Posted
- February 8, 2016
- Terminated
- April 3, 2017
- Recall Number
- Z-0767-2016
- Quantity
- 4
- Firm Location
- Littleton, MA
Reason for Recall
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.
Distribution
US nationwide distribution including FL, NJ, OK, and MO.
Lot / Code Info
Manufacturing Lot or Serial Number: S250-0004
Root Cause
Labeling design
Action Taken
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.
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