Recall Z-2173-2018 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235 The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and
| Date | Aug 7, 2016 |
| Status | Terminated |
| Reason | IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement. |
| Root cause | Employee error |
| Action | IBA mailed out a Field Safety Notice on August 2, 2016, to affected customers where this maintenance is not performed by IBA technicians to inform them of the issue. For further questions please call (215) 972-7985. |
| Quantity | 19 units |
| Distribution | Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132919 | GANTRY BEAM LINE Ion Beam Applications S.A., Jul 10, 2014 |