Recall Z-2139-2018 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus ONE and Proteus Plus
| Date | Sep 16, 2016 |
| Status | Terminated |
| Reason | IBA is initiating this recall to notify its customers that the use of non-IBA accessories and/or third party equipment or unauthorized modifications to an IBA medical device may pose a safety risk. |
| Root cause | Finished device change control |
| Action | IBA mailed an Urgent Field Safety Notice to affected customers on 09/16/2016 to notify them of the risks associated with the use of this device to prevent serious injury/death. Customers were asked not to make any unauthorized modification to the IBA System or IBA accessories unless approved in writing or in advance by IBA. IBA will be updating their manuals to include these warnings. |
| Distribution | Units were delivered in the USA, Korea, Germany, France, Czech Republic, Italy, Poland and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152224 | Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) Ion Beam Application S.A., Aug 9, 2016 |