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  • Dispositivo 1229
  • Fabricante 1229
  • Evento 1230
  • Implante 0
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 041 11 12 000
  • Fecha de inicio del evento
    2012-11-12
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2562
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The problem associated with the affected product is the risk of stress cracks developing in the blade tip that may not be readily visible during routine inspection prior to intubation. this cracking may eventually cause the product to fail.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 025 01 13 000
  • Fecha de inicio del evento
    2013-01-13
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2858
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Vascutek has received a number of events involving graft bleeding including anastomotic bleeding and suture hole bleeding, either during or shortly after surgery.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 070 07 14 000
  • Fecha de inicio del evento
    2014-07-16
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6145
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    This notice is to inform you about important updates to the above products and their instructions for use (ifu).
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 049 02 11 000
  • Fecha de inicio del evento
    2011-02-21
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=150
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    When an image sequence template is added to a field in rt chart and a ciao (completely irradiated aperture opening) is calculated, the resulting ciao display at 4ditc may be incorrect.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 013 07 14 000
  • Fecha de inicio del evento
    2014-07-03
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=6086
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    May exhibit unexpected 6mv beam output variations.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 036 01 19 000
  • Fecha de inicio del evento
    2019-01-14
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13745
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Varian medical systems has identified a problem in aria oncology information system (ois) for radiation oncology such that a user may inadvertently chart medical record information in an unintended patient’s chart.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 016 06 12 000
  • Fecha de inicio del evento
    2012-06-04
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1874
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    A software anomaly has been identified in truebeam when using respiratory gating with patients treated in the prone position. the anomaly is the respiratory gating curve is inverted when a prone patient plan is loaded into truebeam.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 135 06 12 000
  • Fecha de inicio del evento
    2012-06-25
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1999
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The rectal retractors have shown evidence that contaminates, or fluids, have entered into the center of the rectal retractor paddle through the cross pins or bottom rod areas. using a part in this condition could result in infection, toxicity, or allergic reaction.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 012 01 11 000
  • Fecha de inicio del evento
    2011-01-08
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=27
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR, MHRA
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    This advisory notice is to provide you with updated information on multi-isocenter plan management and acquisition of couch parameters for multi-isocenter plans at the 4ditc.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 094 01 12 000
  • Fecha de inicio del evento
    2012-01-25
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1301
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Varian states that excessive connector resistance on the above devices may cause the jaw positions to differ from the intended jaw positions without warning the operator, potentially affecting treatment.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 066 08 11 000
  • Fecha de inicio del evento
    2011-08-22
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=775
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    The 4d integrated treatment console (4ditc) is scheduled for a mandatory upgrade from your current version to 10.2. the reason for the upgrade is to ensure customers have the most current version of 4ditc which contains several improvements to address issues related to proper recording of treatment information from varian machines.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 034 04 13 000
  • Fecha de inicio del evento
    2013-04-09
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=3403
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    While operating with the 6-dot marker block, above version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 031 04 11 000
  • Fecha de inicio del evento
    2011-04-10
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=321
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    The wedge angle labeling on the wedge tray may not correctly match the wedge body. in all cases the wedge body is labeled with the correct wedge angle.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 121 02 12 000
  • Fecha de inicio del evento
    2012-02-19
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1452
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    A possibility of a varian mlc interfering with the treatment field of a demountable brainlab m3 micro-mlc without an interlock being asserted.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 017 09 12 000
  • Fecha de inicio del evento
    2012-09-02
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2264
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    An outdated assigned hounsfield unit [hu] value can be used for dose calculation when the clock on the eclipse client workstation is not synchronized with the database/system server.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 105 07 11 000
  • Fecha de inicio del evento
    2011-07-30
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=702
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    The treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the mu or calculated dose distribution.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 028 07 11 000
  • Fecha de inicio del evento
    2011-07-09
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=625
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    In affected eclipse versions, user editing of mlc leaf positions may not automatically invalidate calculated dose distributions.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 003 01 11 000
  • Fecha de inicio del evento
    2011-01-02
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=18
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Varian has identified an installation anomaly whereby the bolts used to fasten the counterweight to the gantry may not, in some cases, be fully tightened to the required torque specification. in the worst possible scenario this could result in the counterweight detaching from the gantry; and the resulting unbalanced gantry may swing freely, posing a hazard of a collision with a patient, therapist, or service person.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 085 01 11 000
  • Fecha de inicio del evento
    2011-01-31
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=100
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    A system was discovered where vmat (volumetric modulated arc therapy) plans were delivered as dynamic arc. it was determined that an older configuration of the clinac and older version and configuration of the linac vi software which did not recognize vmat plans was inadvertently installed.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 031 10 15 000
  • Fecha de inicio del evento
    2015-10-11
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8345
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Admin instructions may not print on drug order prescriptions or be transmitted with e-rx. when the user changes the prescription “type” field after inputting admin instructions in the text box, the admin instructions portion of the prescription will not be saved to the database. an e-rx transmitted to the pharmacy will not contain the intended admin instructions.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 093 08 18 000
  • Fecha de inicio del evento
    2018-08-29
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13091
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Varian medical systems has received reports of an anomaly that can result in a treatment without intended gating. this issue occurs when a patient planned with gating is treated on more than one truebeam system [includes: truebeam, truebeam stx, vitalbeam or edge]. varian has not received any reports of injury due to this issue. the issue only affects truebeam systems version 2.0, 2.5 and 2.5 mr1.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 019 07 12 000
  • Fecha de inicio del evento
    2012-07-08
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=2041
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    If the dose prescription of a vmat or rapidarc plan is changed after the initial dose volume optimization, the monitor units and dose distribution may not reflect the intended prescription. affects eclipse v8.5 to v11.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 146 03 14 000
  • Fecha de inicio del evento
    2014-03-31
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=5567
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The shaft of the type 01 elbow motor for exact arms used in the on-board imager® [obi] device have failed due to belt over-tensioning. this over tensioning would have taken place during servicing. this failure would allow the exact arm to swing freely with gravity. no injuries have been reported to-date. only type 01 elbow motors are subject to these potential failures, type 02 elbow motors are not affected.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 078 12 13 000
  • Fecha de inicio del evento
    2013-12-09
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=4936
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The plan parameters workspace within eclipse™ treatment planning system, aria® radiation oncology, aria® radiation therapy management, and acuity™. when a dose relevant parameter is changed and “do not clear mus and reference point dose” is selected, the monitor units (mus) may change.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 065 08 11 000
  • Fecha de inicio del evento
    2011-08-22
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=774
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company
  • Causa
    Anomaly in eclipse versions 8.0 to 8.6 whereby a particular plan approval workflow may result in a difference between the intended ssd value and the ssd value communicated to the treatment delivery system.
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