Recall Z-0938-2018— Ion Beam Applications S.A.

Name: FDA recall Z-0938-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-17

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2017-11-17, terminated 2021-06-14. It names one FDA 510(k) clearance: K101508. Product: Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.. Reason: There is a risk of misalignment of the patient when using treatment plans with multiple isocenters..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Terminated: 2021-06-14
Firm location: Louvain La Neuve, Belgium

510(k) clearances named in this recall

1 on FDA's record

K101508 — MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235Ion Beam Applications S.A.·cleared 2010-08-06

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, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

Reason for recall

There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.

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