FDA-Device2016-02-17Class II

MEVION S250 Radiation therapy system

Mevion Medical Systems, Inc.
Hazard

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.

Sold states
US nationwide distribution including FL, NJ, OK, and MO.
Affected count
4
Manufactured in
300 Foster Street, N/A, Littleton, MA, United States
Products
MEVION S250 Radiation therapy system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0767-2016

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