Recall Z-1603-2024— Ion Beam Applications S.A.

Name: FDA recall Z-1603-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-04

Class II · Ongoing

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2024-03-04. It names one FDA 510(k) clearance: K163500. Product: IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.. Reason: There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-04
Firm location: Ottignies-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

IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

Reason for recall

There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

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