Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Issue 1: cardiac signal not found in workflow issue if the operator loads a cardiac exam card the cardiac signal is shown during cardiac scan but not shown during the surview. issue 2: scan may start at the top of the head which may not be where the operator is expecting the scan to start if the operator plans to do multiple scans with multiple results including identical links then the first result of the subsequent acquisition will follow the last result of previous acquisition and not the identical link of the previous acquisition. the possible outcome is that the results of the second scan could be planned outside the boundaries of the expected results. issue 3: pulmo gates on cardiac workflow issue if the operator loads a cardiac exam card after performing a pulmonary scan the pulmo wave may be present. issue 4: in the plan viewer if the start position is modified the total length of the acquisition will changes as well. in the plan viewer if the start position is modified by the length of one slice thickness then the total length of the acquisition may change by the same length value as well. note this occurs only when planning without a surview. issue 5: image volumes are not found in patient directory when thin images are included in one of the multiple results the operator completes a ct orbit procedure and clicks 'end study'. the final thin images may not appear in patient directory. when the operator clicks 'recon' to attempt to do an off-line recon the 'view 2' application may fail. issue 6: application may fail when modifying the results plan box during 3d calcium score while setting up a 3d calcium score scan if the operator attempts to modify the plan box of a result on the surview the application may fail and require a restart. issue 7: tube too hot the operator presses 'go' to execute a timed scan sequence and the following message may display: "tube too hot". issue 8: memory overflow issue when performing a ct clinical procedure it is possible that the scan may be aborted as a result of a memory overflow issue. issue 9: while the reconstruction is in progress disconnecting the recon box (cirs) may not give error message when the connection between host computer and recon box (cirs) is disrupted during reconstruction the operator may not be informed and may require that the operator reconstruct the images through off-line reconstruction. issue 10: issue with the generatormonitor state machine in rhost code when the operator turns the key switch on the ct box to 'off' and turns it back on before the system gantry is turned off completely the system might make the generator to go into a configuration state and ceases to monitor and to send the updated real time data for the tube's kv and ma. raison du rappel probleme 1 : signal cardiaque non trouve dans le flux de travail si l'operateur charge une carte d'examen cardiaque le signal cardiaque s'affiche pendant l'acquisition cardiaque mais pas pendant l'acquisition preliminaire. probleme 2 : l'acquisition pourrait commencer sur le dessus de la tete ce qui pourrait ne pas etre l'endroit oe l'operateur s'attend e voir l'acquisition commencer. si l'operateur prevoit faire plusieurs acquisitions avec resultats multiples y compris des liens identiques le premier resultat de l'acquisition subsequente suivra le dernier resultat de l'acquisition precedente et non le lien identique de l'acquisition precedente. resultat possible : les resultats de la deuxieme acquisition pourraient etre planifies en dehors des limites des resultats attendus. probleme 3 : synchronisation pulmonaire dans un flux de travail cardiaque si l'operateur charge une carte d'examen cardiaque apres avoir effectue une acquisition pulmonaire l'onde pulmonaire pourrait etre presente. probleme 4 : si la position de depart est modifiee dans la visionneuse de plan la duree totale de l'acquisition changera egalement. dans la visionneuse de plan si la position de depart est modifie en fonc.