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 neck.
Recall
- Recall Number
- Z-2173-2018
- Event Number
- 80222
- FEI Number
- 3000256071
- Product Code
- LHN
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- August 7, 2016
- Terminated
- March 25, 2020
- Address
- Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium
Description
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 neck.
IBA is recalling to provide information through a Safety Notice to reduce risk for maintenance technicians during ion source replacement.
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.
Units were distributed in the USA, Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden. Each country's national Competent Authorities have been informed.
19 units