Ion Beam Applications S.A. recalls Proteus 235

Recall date

February 9, 2017

Source

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

Recall number

Z-2592-2017

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

Worldwide Distribution - US Distribution to the states of : MA, FL, VA, PA, IL, NJ, WA, TN, LA and TX., and to the countries of: Germany, South Korea, France, Czech Republic, Italy, Poland and Sweden.

Why it was recalled

It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.

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 235