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Ion Beam Applications S.A. recalls Proteus ONE and Proteus Plus
Recalled June 20, 2018 · FDA recall Z-2139-2018 · 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. · FDA Class II
Units
N/A
Sold at
Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden.
Description
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.
Product
Proteus ONE and Proteus Plus
Manufacturer(s)
Ion Beam Applications S.A.
Made in
Belgium
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →