Company:Philips Medical Systems (Cleveland) Inc
Date of Enforcement Report 2/21/2018
Class lI:
PRODUCT
Ingenuity TF PET/CT (model 882442) running software version 4.0.2This 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.
Recall Number Z-0562-2018
REASON
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 to be reconstructed and will therefore be unusable
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc, Cleveland, OH on 12/11/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
24
DISTRIBUTION
Worldwide Distribution – US Distribution to the states of : CA, OH, IL, PA and NY.
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