FDA recall Z-2672-2017

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

Product

Proteus 235 and Proteus ONE proton therapy systems

Reason for recall

Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

Distribution

Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden

Key facts

Status
Terminated
Initiation date
2016-05-18
Report date
2017-07-12
Termination date
2019-02-08
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-2672-2017