Recall Z-3089-2024— Ion Beam Applications S.A.

Name: FDA recall Z-3089-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-08

Class II · Ongoing

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2024-07-08. It names one FDA 510(k) clearance: K163500. Product: IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions. Reason: Safety Parameters Verification Mechanisms can be deactivated in clinical runtime.

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Ongoing
Initiated: 2024-07-08
Firm location: Ottignies-Louvain-La-Neuve, 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

IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

Reason for recall

Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

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