Ion Beam Applications S.A.: IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

Hazard

There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.

Details from the source

Reason for recall: There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance. Distribution: US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA. Quantity: 8 units Lot/code info: 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.

UPC codes

05404013801138

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.