Proteus 235, Proton Therapy System
FDA Recall Z-1830-2017 · Posted None
Recalling FirmIon Beam Applications S.A.
Recall StatusTerminated
Product CodeLHN
Date Initiated2017-03-21
Date Terminated2018-09-19
Product Quantity2 worldwide, 1 in U.S.
Reason for Recall
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
Firm Action
A Field Safety Notice was mailed to the customer affected by the issue on 03/21/2017. The Notice informed the user when resuming from a partial irradiation, to ensure that the correct delivered dose has been selected in the partial report dialog box before proceeding with irradiation.
Root Cause
Software design
Distribution Pattern
Distribution in US (to Louisiana), and France.
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.