PlainRecalls
FDA Devices Moderate Class II Terminated

MEVION S250 Product Usage: Proton Radiation Therapy

Reported: November 23, 2016 Initiated: October 31, 2016 #Z-0409-2017

Product Description

MEVION S250 Product Usage: Proton Radiation Therapy

Reason for Recall

Completing Setup Without Program Move Complete Can Cause An Isocenter Error

Details

Units Affected
6 units
Distribution
US Nationwide in the states of FL, MO, NJ and OK
Location
Littleton, MA

Frequently Asked Questions

What product was recalled?
MEVION S250 Product Usage: Proton Radiation Therapy. Recalled by Mevion Medical Systems, Inc.. Units affected: 6 units.
Why was this product recalled?
Completing Setup Without Program Move Complete Can Cause An Isocenter Error
Which agency issued this recall?
This recall was issued by the FDA Devices on November 23, 2016. Severity: Moderate. Recall number: Z-0409-2017.