medical Class II Updated 2023-11-22

Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PT

Recalled Product

IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.

Hazard / Issue

The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125.
View official government recall

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