Retiro De Equipo (Recall) de BRILLIANCE ICT SP SYSTEM - MAIN

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS LTD..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    Issue 1: scan parameters exceeds system resources: during a bolus tracking procedure: if the operator sets the roi on the locator slice and then presses "go" to initiate the tracker scans the following message may display: "scan parameters exceeds system resources". if the message is displayed the system will fail to proceed with the tracker scan. 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: error message appears stating: "the exam application stopped working" and will instruct the operator to close the program: during a cct procedure an error message may appear "the exam application stopped working close the program". when the operator closes the program a 'system error' will appear and the application will fail and require restart. issue 4: during a bolus tracking procedure after acquiring the surview locator and tracker the scanner may move into place give the patient breathing instructions and then fail to acquire the scan: during a bolus tracking procedure with a clinical scan that exceeds 118 seconds in duration the following may occur: once the bolus tracking threshold is reached the couch will move into the planned positon for the clinical scan but fail to acquire the scan. 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 the 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: if the operator attempts to modify the plan box of a result on the surview while setting up a 3d calcium score scan 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: 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. this may require that the operator reconstruct the images through off-line reconstruction. issue 10: in the plan viewer if the start position is modified the total length of the acquisition will change 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. note this occurs only when planning without a surview.


  • Modelo / Serial
    Model Catalog: 728311 (Lot serial: 200208); Model Catalog: 728311 (Lot serial: 200213); Model Catalog: 728311 (Lot serial: 100619); Model Catalog: 728311 (Lot serial: 100616); Model Catalog: 728311 (Lot serial: 100101); Model Catalog: 728311 (Lot serial: 100440); Model Catalog: 728311 (Lot serial: 100223); Model Catalog: 728311 (Lot serial: 100195); Model Catalog: 728311 (Lot serial: 100638)
  • Descripción del producto
  • Manufacturer


  • Dirección del fabricante
  • Empresa matriz del fabricante (2017)
  • Source