FDAFDA · Food and drugs·Recall number Z-2715-2020
Proteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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.
Published August 5, 2020 · Recall initiated: July 17, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
IBA became aware of an issue to resume aborted irradiations because the plan to complete the treatment cannot be loaded.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- US: VA OUS: Belgium
- Lot
- Serial Number: Manufacture date SAT.140 (US): manufactured May 2019 SBF.112 (EU): manufactured October 2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
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