Recall Z-2139-2018— Ion Beam Applications S.A.

Name: FDA recall Z-2139-2018
Creator: U.S. Food and Drug Administration
Published: 2016-09-16

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2016-09-16, terminated 2019-02-08. It names one FDA 510(k) clearance: K152224. Product: Proteus ONE and Proteus Plus. Reason: IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2016-09-16
Terminated: 2019-02-08
Firm location: Louvain La Neuve, N/A, 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 ONE and Proteus Plus

Reason for recall

IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk.

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