Recall Z-2672-2017 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235 and Proteus ONE proton therapy systems
| Date | May 18, 2016 |
| Status | Terminated |
| Reason | Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures. |
| Root cause | Employee error |
| Action | An Urgent Field Safety Notice MID-54097 was mailed to affected customers to inform that IBA plans to deploy a new software by March 2017 to correct the issue. Customers were reminded to follow standard protocol until the software updates are deployed. |
| Quantity | 18 worldwide and 10, in the U.S. |
| Distribution | Products distributed to FL, VA, PA, OK, IL, NJ, WA, TN, LA, TX, South Korea, Germany, France, Czech Republic, Italy, Poland, and Sweden |
| 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 |