FDA (Devices) recall action 80221
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Ion Beam Applications S.A. is recalling 12C medical devices because using non-IBA accessories or unauthorized modifications may pose a safety risk.
Ion Beam Applications is recalling Proteus ONE and Proteus Plus medical devices because unauthorized modifications or third-party accessories may pose a safety risk.