FDA recall Z-2139-2018

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

Product

Proteus ONE and Proteus Plus

Reason for recall

IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.

Distribution

Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.

Key facts

Status: Terminated
Initiation date: 2016-09-16
Report date: 2018-06-20
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-2139-2018