Ion Beam Applications S.A.: Medical Device Recall in 2017 - (Recall #: Z-2097-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Proton therapy system -Proteus 235 aka Proteus Plus. 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 10, 2017

Date Posted: May 24, 2017

Recall Number: Z-2097-2017

Event ID: 76977

Reason for Recall:

A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.

Status: Terminated

Product Quantity: 2

Code Information:

Serial numbers: PAT.003, PAT.006

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated