Ion Beam Applications S.A.: Medical Device Recall in 2018 - (Recall #: Z-0938-2018)

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, Proton Therapy System a medical device designed to produce and delivers 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: November 17, 2017

Date Posted: March 21, 2018

Recall Number: Z-0938-2018

Event ID: 79230

Reason for Recall:

There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.

Status: Terminated

Product Quantity: 37

Code Information:

PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.126 (US), SAT.132 (EU), SAT.133 (US), SBF.101 (EU), SBF.105 (US)

Distribution Pattern:

Nationally

Voluntary or Mandated:

Voluntary: Firm initiated