Recall Z-2424-2018 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A 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.
| Date | Jun 20, 2018 (initiated May 16, 2018) |
| Status | Terminated |
| Reason | Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position. |
| Root cause | Software design |
| Action | On May 18, 2018 IBA issued URGENT FIELD SAFETY NOTICES to their customers. Customers were advised to take the following actions: It is recommended to ensure that the correction vector confirmation message appears on the expected access point. When the correction vector is applied (if deemed necessary1), ensure that the Patient Positioning System GoTo the corrected position for treatment before starting irradiation: - verify on adaPTdeliver screen that the corrected target position is selected before engaging the movement. - verify on adaPTdeliver screen that the corrected target position a |
| Quantity | 3 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101508 | MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 Ion Beam Applications S.A., Aug 6, 2010 |