Recall Z-0466-2022— Ion Beam Applications S.A.

Name: FDA recall Z-0466-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-29

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2021-11-29, terminated 2024-02-20. It names one FDA 510(k) clearance: K163500. Product: Proteus 235; Version: PTS-8 versions before PTS-8.7.2. Reason: 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..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2021-11-29
Terminated: 2024-02-20
Firm location: Louvain-la-neuve, N/A, Belgium

510(k) clearances named in this recall

1 on FDA's record

K163500 — IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)Ion Beam Applications S.A.·cleared 2017-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.