Z-0767-2016 Class II Terminated
FDA device recall Z-0767-2016 was initiated by Mevion Medical Systems, Inc. on November 18, 2015 and is designated Class II. 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 … The recall status is terminated (terminated April 3, 2017). Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2016
- Initiation Date
- November 18, 2015
- Termination Date
- April 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
Product Description
MEVION S250 Radiation therapy system
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 Pattern
US nationwide distribution including FL, NJ, OK, and MO.
Code Information
Manufacturing Lot or Serial Number: S250-0004