Recall Z-2672-2017— Ion Beam Applications S.A.

Name: FDA recall Z-2672-2017
Creator: U.S. Food and Drug Administration
Published: 2016-05-18

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2016-05-18, terminated 2019-02-08. It names one FDA 510(k) clearance: K132919. Product: Proteus 235 and Proteus ONE proton therapy systems. Reason: Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2016-05-18
Terminated: 2019-02-08
Firm location: Louvain La Neuve, N/A, Belgium

510(k) clearances named in this recall

1 on FDA's record

K132919 — GANTRY BEAM LINEIon Beam Applications S.A.·cleared 2014-07-10

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 and Proteus ONE proton therapy systems

Reason for recall

Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.

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