ClearanceBrief
Recall Z-2773-2020 ยท LHN System, Radiation Therapy, Charged-Particle, Medical

Ion Beam Applications S.A.

Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

DateApr 21, 2020
StatusTerminated
ReasonSignature from the user is necessary to proceed with specific actions in the Proton Therapy System (PTS). IBA became aware that the PTS does not accept user names with more than ten characters. It is an issue when the user has no other choice than resuming an aborted treatment field based on the overall delivered dose displayed on the Dose Counter Electronic Unit (DCEU). User s signature is required to perform this action. If the signature contains more than ten characters, the user will not be able to complete the aborted treatment field. An additional issue applies to Electronic Medical Reco
Root causeSoftware design
ActionIBA sent a customer communication letter dated May 8, 2020. This letter explained to the customers, it is recommended to redefine any user name that contains more than ten characters to a user name with up to ten characters. Software upgrade IBA will remove the limitation on the allowed length of the user name in the database. IBA will modify the list of criteria that guarantee proper matching between the treatment field being resumed and the treatment field that was interrupted: patient position from the beam report will be used instead of the PPS position. The solutions will be deployed on y
Quantity4 units
DistributionWorldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K163500IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)
Ion Beam Applications S.A., Aug 17, 2017