Recall Z-2097-2017— Ion Beam Applications S.A.

Name: FDA recall Z-2097-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-10

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2017-04-10, terminated 2018-02-16. It names one FDA 510(k) clearance: K152224. Product: Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.. Reason: A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2017-04-10
Terminated: 2018-02-16
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

Proton therapy system -Proteus 235 aka Proteus Plus. A medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Reason for recall

A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.

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