Ion Beam Applications S.A.: 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

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

Details from the source

Reason for recall: The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices. Distribution: Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan. Quantity: 5 (US), 9 (OUS) 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.

UPC codes

05404013801138

Source

Official record: FDA (Device enforcement) ↗

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