Recall Z-0295-2024— Ion Beam Applications S.A.

Name: FDA recall Z-0295-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-18

Class II · Ongoing

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2023-09-18. It names one FDA 510(k) clearance: K163500. Product: IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.. Reason: The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-18
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-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.

Reason for recall

The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

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