FDAFDA · Food and drugs·Recall number Z-2684-2017
Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 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 July 12, 2017 · Recall initiated: December 13, 2016
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
Software issue
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- Distributed to FL, VA, IL, NJ, WA and South Korea
- Lot
- Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.