Recall Z-2284-2018— Ion Beam Applications S.A.
Class II · Terminated
Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2016-04-11, terminated 2020-03-25. It names one FDA 510(k) clearance: K152224. Product: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS). Reason: IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue..
- Recalling firm
- Ion Beam Applications S.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-11
- Terminated
- 2020-03-25
- Firm location
- Louvain La Neuve, 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
The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
Reason for recall
IBA is conducting a voluntary recall to address a PTS (Proton Therapy System) software issue and to reduce the risk related to this issue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.