FDA recall Z-0930-2018

Ion Beam Applications S.A. · Class II · device

Product

Proteus 235, graphite block 8

Reason for recall

IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader

Distribution

WA

Key facts

Status
Terminated
Initiation date
2017-10-17
Report date
2018-03-14
Termination date
2019-03-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Louvain La Neuve, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0930-2018