FDA-Device2018-06-20Class II
Proteus ONE and Proteus Plus
Ion Beam Applications S.A.
Hazard
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.
Sold states
Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.
Affected count
N/A
Manufactured in
Chemin du Cyclotron, 3, N/A, Louvain La Neuve, N/A, Belgium
Products
Proteus ONE and Proteus Plus
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2139-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief