Ion Beam Applications S.A. recalls 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or phot…

Recall date

October 28, 2016

Source

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

Recall number

Z-2109-2018

FDA classification

Class II

Brand / firm

Ion Beam Applications S.A.

Sold / distributed

Worldwide Distribution - US Nationwide in the states of LA, TX, Italy, Sweden and France. Each country's National Competent Authorities were notified of the firm's Field Safety Notice.

Why it was recalled

IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.

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

What was recalled

12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.