Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-2173-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Proteus 235 The PTS 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

Product Classification:

Class II

Date Initiated: August 7, 2016

Date Posted: June 20, 2018

Recall Number: Z-2173-2018

Event ID: 80222

Reason for Recall:

IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.

Status: Terminated

Product Quantity: 19 units

Code Information:

Code/Serial Numbers: PAT.000, PAT.003, PAT.006, PAT.107, PAT.108, PAT.109, PAT.110, PAT.111, PAT.112, PAT.113, PAT.114, PAT.115, SAT.116, SAT.117, SAT.119, SAT.120, SAT.122, SAT.123, SAT.126.

Distribution Pattern:

Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.

Voluntary or Mandated:

Voluntary: Firm initiated