PlainRecalls
FDA Devices Moderate Class II Terminated

MEVION S250i

Reported: January 16, 2019 Initiated: October 1, 2018 #Z-0705-2019

Product Description

MEVION S250i

Reason for Recall

Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped

Details

Units Affected
1 unit
Distribution
DC
Location
Littleton, MA

Frequently Asked Questions

What product was recalled?
MEVION S250i. Recalled by Mevion Medical Systems, Inc.. Units affected: 1 unit.
Why was this product recalled?
Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
Which agency issued this recall?
This recall was issued by the FDA Devices on January 16, 2019. Severity: Moderate. Recall number: Z-0705-2019.