FDAFDA · Food and drugs·Recall number Z-1603-2024
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Published May 1, 2024 · Recall initiated: March 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Ion Beam Applications S.A.
- Distributor
- US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
- Lot
- PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Belgium
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.