Recall Z-2715-2020— Ion Beam Applications S.A.
Class II · Terminated
Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2020-07-17, terminated 2021-08-30. It names one FDA 510(k) clearance: K163500. Product: Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical 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: IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded..
- Recalling firm
- Ion Beam Applications S.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-17
- Terminated
- 2021-08-30
- Firm location
- Louvain-la-neuve, N/A, Belgium
510(k) clearances named in this recall
1 on FDA's recordK-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 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical 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
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
Data sourced from openFDA. This site is unofficial and independent of the FDA.