Proteus 235
FDA Recall Z-1695-2017 · Posted 2017-03-23
Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2017-03-09
Date Terminated2019-03-26
Product Quantity8 worldwide, 4 in U.S.
Reason for Recall
The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
Firm Action
A Field Safety Notice was mailed or handed to affected customers to inform them of the issue. The notice provides information on the issue, the risk for the patient and user and actions to be taken before starting gantry rotation. Corrective action developed by IBA are detailed.
Root Cause
Component design/selection
Distribution Pattern
Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.