Ion Beam Applications S.A.: Medical Device Recall in 2020 - (Recall #: Z-2773-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 21, 2020

Date Posted: August 19, 2020

Recall Number: Z-2773-2020

Event ID: 86073

Reason for Recall:

Signature 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 Record (EMR) centric sites and may increase the probability of not being able to complete an aborted treatment field. It is not possible, in a new session, to resume from a local partial archive if the Patient Positioning System (PPS) position has changed. If the user captures the PPS position at every session in the Oncology Information System (OIS) just after the setup process, the prescribed PPS position is changed for the next session in the OIS. This includes the partial continuation session. Therefore, when comparing the prescribed PPS position between OIS and local database, the PTS sees a difference and rejects the local partial archive. This problem forces the user to resume the interrupted irradiation based on the overall delivered dose displayed on the DCEU instead of resuming from the full details of the interrupted beam.

Status: Terminated

Product Quantity: 4 units

Code Information:

Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019 SBF.113 (US): manufactured June 2019 SBF.117 (EU): manufactured November 2019

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of FL, VA and the countries of Belgium, Spain.

Voluntary or Mandated:

Voluntary: Firm initiated