Recall Z-0836-2015 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Ion Beam Applications S.A.
adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy device.
| Date | Dec 19, 2014 (initiated Nov 7, 2014) |
| Status | Terminated |
| Reason | Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific mode of acquisition. 2. A gantry collision incident required the IBA service team to verify the gantry alignment and protons I x-ray beams colinearity, du |
| Root cause | Software design (manufacturing process) |
| Action | The firm, IBA, sent a " User Notice" dated November 7, 2014, to the sole affected site-UPHS Customer. The notice describes the product, problem and actions to be taken. The customer was instructed that the KV/kV source acquisition mode has been disabled and shall not be used for patient alignment until system is officially confirmed to be back within tolerances. IBA will change the kV/kV Single Source acquisition workflow configuration file to be linked to the correct geometrical calibration file and will update the kV/kV Single Source calibration file that includes the colinearity parameters |
| Quantity | 1 |
| Distribution | US Distribution in PA only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132847 | I2C Ion Beam Applications S.A., Nov 20, 2013 |