Recall Z-1695-2017— Ion Beam Applications S.A.

Name: FDA recall Z-1695-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-09

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2017-03-09, terminated 2019-03-26. It names one FDA 510(k) clearance: K101508. Product: Proteus 235. Reason: The Proton Therapy System can allow gantry rotation even if the snout is not properly locked..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2017-03-09
Terminated: 2019-03-26
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

Reason for recall

The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.

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