Recall Z-2155-2021— Ion Beam Applications S.A.

Name: FDA recall Z-2155-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-26

Class II · Ongoing

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2021-05-26. It names one FDA 510(k) clearance: K101508. Product: Proteus 235-Proton Therapy System. Reason: if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position.

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Ongoing
Initiated: 2021-05-26
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-Proton Therapy System

Reason for recall

if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position

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