Recall Z-2424-2018— Ion Beam Applications S.A.

Name: FDA recall Z-2424-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-16

Class II · Terminated

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2018-05-16, terminated 2018-10-16. It names one FDA 510(k) clearance: K101508. Product: Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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: Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position..

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Terminated
Initiated: 2018-05-16
Terminated: 2018-10-16
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, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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

Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.

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