Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

IBA issued Urgent Medical Device Correction notification on February 15, 2022 directly to customer either by hand or by email. Letter states reason for recall, health risk and action to take: For Proton Therapy sites where the system is operated by the customer: - Warn operators to not manually change the beam range (action called manual set range ) while a patient is on the Patient Positioning System. - IBA will provide a training to all operators about the correct use of the action called manual set range and the risk associated to its use while a patient is on the Patient Positioning System. This training will be provided on your site by August 31, 2022. Contact: Vigilance@iba-group.com. Help Desk: +32 2 507 20 81 (available 24/7)

Distribution

As reported by FDA

FL, IL, KS, LA, MI, NJ, OK, PA, TN, TX, VA, WA