Recall Z-0747-2022— Ion Beam Applications S.A.
Class II · Ongoing
Class II FDA medical device recall by Ion Beam Applications S.A., initiated 2022-02-15. It names one FDA 510(k) clearance: K163500. Product: ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235. Reason: When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range.
- Recalling firm
- Ion Beam Applications S.A.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-02-15
- 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
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
Reason for recall
When resuming from a beam pause, the Proton Therapy System does not verify whether the beam range has not been manually modified during the pause and is still the prescribed one. Therefore, if an operator manually modified the range during a pause, there is a risk that a portion of the treatment beam after the resume is delivered with an error in range
Data sourced from openFDA. This site is unofficial and independent of the FDA.