Recall Z-0930-2018— Ion Beam Applications S.A.

Name: FDA recall Z-0930-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-17

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2017-10-17, terminated 2019-03-29. It names one FDA 510(k) clearance: K101508. Product: Proteus 235, graphite block 8. Reason: IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader.

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2017-10-17
Terminated: 2019-03-29
Firm location: Louvain La Neuve, N/A, 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, graphite block 8

Reason for recall

IBA identified incorrect screw holes depth in graphite block 8 with respect to the degrader

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