Recall Z-1205-2022— Ion Beam Applications S.A.

Name: FDA recall Z-1205-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-20

Class II · Ongoing

Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2022-04-20. It names one FDA 510(k) clearance: K163500. Product: Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. Reason: First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed.

Recalling firm: Ion Beam Applications S.A.
Classification: Class II
Status: Ongoing
Initiated: 2022-04-20
Firm location: Louvain-la-neuve, N/A, Belgium

510(k) clearances named in this recall

1 on FDA's record

K163500 — IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class)Ion Beam Applications S.A.·cleared 2017-08-17

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

Proteus235- Proton Therapy System: 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

First layer of Uniform Scanning treatment fields is sometimes irradiated with incorrect Scanning Magnet setpoints resulting in the field size may be smaller than expected and the irradiated area may receive more dose than prescribed

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