FDAFDA · Food and drugs·Recall number Z-0931-2018
Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X 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. 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.
Published March 14, 2018 · Recall initiated: October 19, 2017
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
Range for the same energy could be different depending if the layer is the first layer of the irradiation plan or not.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- US Distribution to the state of :FL
- Lot
- PAT.003 (KR), PAT.006 (US)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
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