Company: on Beam Applications S.A.
Date of Enforcement Report 12/31/2014
Class lI:
PRODUCT
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. Recall Number Z-0836-2015
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, during which the colinearity parameters was changed. This was done for the Cone Beam Computed Tomography and kV/kV Dual Sources acquisition modes (the associated config ration file was modified), but not for the kV/kV Single Source acquisition mode (which requires to change another configuration file)..
RECALLING FIRM/MANUFACTURER
on Beam Applications S.A.A, Louvain La Neuve, BE on 11/7/2014. Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
US Distribution in PA only.
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