Ion Beam Applications S.A.: Medical Device Recall in 2022 - (Recall #: Z-0466-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Proteus 235; Version: PTS-8 versions before PTS-8.7.2

Product Classification:

Class II

Date Initiated: November 29, 2021

Date Posted: January 19, 2022

Recall Number: Z-0466-2022

Event ID: 89267

Reason for Recall:

Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.

Status: Terminated

Product Quantity: 5 devices

Code Information:

PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).

Distribution Pattern:

IN USA: VA, OK, NJ, TN OUS: Czech Republic.

Voluntary or Mandated:

Voluntary: Firm initiated