Recall Z-2173-2018— Ion Beam Applications S.A.
Class II · Terminated
Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2016-08-07, terminated 2020-03-25. It names one FDA 510(k) clearance: K132919. Product: Proteus 235 The PTS 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.. Reason: IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement..
- Recalling firm
- Ion Beam Applications S.A.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-07
- Terminated
- 2020-03-25
- 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 PTS 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Reason for recall
IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
Data sourced from openFDA. This site is unofficial and independent of the FDA.