Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Philips Healthcare.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 137 02 18 000
  • Date de mise en oeuvre de l'événement
    2018-02-27
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12216
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Upon closing the emergency stop (e-stop) the system performs an internal check. as a result of the motion controller in the couch, there is a delay in the response to the internal check. this delay may cause the couch carbon top to enter a free float state, which may allow it to move during patient load or unload activities. this free float motion results in the estop being opened due to the unexpected couch motion.

Device

Ingenuity Flex, Ingenuity CT, Ingenuity Core, Ingenuity Core128, Brilliance iCT, Brilliance iCT S...
  • Modèle / numéro de série
    Ingenuity Flex - 728317 Ingenuity CT - 728326, 728325 Ingenuity Core - 728321 Ingenuity Core128 - 728323, 728324 Brilliance iCT - 728306 Brilliance iCT SP - 728311 Brilliance Big Bore (Oncology) - 728243 Brilliance Big Bore (Radiology) - 728244 Brilliance 16 Slice (Air) - 728246 Brilliance 16 Slice (Power) - 728240 Brilliance 40 - 728235 Brilliance 64 - 728231 IQon Spectral CT - 728332 Brilliance 6 Slice (Air) - 728256 Brilliance 10 Slice (Air) – 728251 Brilliance CT Private Practice CV config. - 728241
  • Description du dispositif
    Scanning Systems, Computed Tomography
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Société-mère du fabricant (2017)
    Philips
  • Représentant du fabricant
    Al-Faisaliah Medical System, Riyadh, (01) 2119948
  • Source
    SFDA