Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). CT data is applied to the PET data for attenuation correction. The PET subsystem also provides for list mode, dynamic, and gated acquisitions. This system is intended for patients of all ages
A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. This error has been found to occur in two scenarios: 1) When the system operator cancels an acquisition a. The error will occur every time a scan is cancelled by the operator. 2) Couch position requests within the software sequence were delayed a. The error occurs intermittently, but has been found to occur more frequently when the gantry s network is heavily loaded with multiple retrospective reconstructions running in parallel. b. The error manifests to the technologist by an error message and Failed status on the Reconstruction Monitor and the error message Result {0} failed to reconstruct" on the Acquisition Workflow window during reconstruction after the patient scan has been completed. In both scenarios, the acquisition data will not be able
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https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0562-2018