PlainRecalls
FDA Devices Moderate Class II Terminated

MEVION S250 Radiation therapy system

Reported: February 17, 2016 Initiated: November 18, 2015 #Z-0767-2016

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.

Details

Units Affected
4
Distribution
US nationwide distribution including FL, NJ, OK, and MO.
Location
Littleton, MA

Frequently Asked Questions

What product was recalled?
MEVION S250 Radiation therapy system. Recalled by Mevion Medical Systems, Inc.. Units affected: 4.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 17, 2016. Severity: Moderate. Recall number: Z-0767-2016.