Recall Z-2434-2021— Ion Beam Applications S.A.
Class II · Ongoing
Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2021-06-14. It names one FDA 510(k) clearance: K061913. Product: Proteus 235- 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: Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment.
- Recalling firm
- Ion Beam Applications S.A.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-06-14
- 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- 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
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Data sourced from openFDA. This site is unofficial and independent of the FDA.