Ion Beam Applications S.A. recalls Proteus ONE and Proteus Plus

Recall date

September 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2139-2018

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Proteus ONE and Proteus Plus