Recall Z-0943-2018 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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 treatme
| Date | Nov 1, 2017 |
| Status | Terminated |
| Reason | The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment. |
| Root cause | Device Design |
| Action | The firm, IBA, sent an "Urgent Field Safety Notice" dated 10/31/2017 to customers on 10/31/2017. The notice described the product, problem and actions to be taken. stating the following: There is no specific recommendation for the user. IBA will provide an Internal User notice to the IBA site team, requesting the operator to select the Beam Delivery Point CGTR, by clicking on the BDP button, before each patient treatment preparation (see Annex 1 for details). This will begin the check of the internal configuration of all the elements of the Dekimo Scanning Controller. An updated system wil |
| Quantity | 3 |
| Distribution | Worldwide Distribution: US (nationwide) to: MI only and country of: France. |
| 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 |