Recall Z-2592-2017— Ion Beam Applications S.A.

Name: FDA recall Z-2592-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-09

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2017-02-09, terminated 2023-07-14. It names one FDA 510(k) clearance: K152224. Product: Proteus 235. Reason: It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2017-02-09
Terminated: 2023-07-14
Firm location: Louvain La Neuve, Belgium

510(k) clearances named in this recall

1 on FDA's record

K152224 — Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A.·cleared 2016-08-09

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

Reason for recall

It has been observed during testing that there could be clinically non-negligible amount of dark current (a well-known physics effect observed in cyclotron) in Pencil Beam Scanning (PBS) treatment mode when system is not irradiating between layers.

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