Reported Nov 22, 2023 · Ongoing
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured…
Ion Beam Applications S.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ion Beam Applications S.A. · Chemin Du Cyclotron 3 · Ottignies-Louvain-La-Neuve, N/A · N/A
Is this the product you have?
- IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
- Lot codes and dates
- UDI-DI(01)05404013801138
- Serial numbers (US)
SAT133SAT140SBF113SBF128
- SBF135 & (OUS)
SAT125SAT127SAT132SAT136SBF107SBF112SBF117SBF124& SBF125
- Amount recalled
- 5 (US), 9 (OUS)
Where it was sold
Why it was recalled
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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