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  • Dispositivo 3309
  • Fabricante 731
  • Evento 124969
  • Implante 166
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 162 11 13 001
  • Fecha de inicio del evento
    2013-12-01
  • 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=4855
  • 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
    Bending iron tips broke while surgeons were attempting to bend a spinal rod. the majority of complaints involve attempts to bend the warm-worked cobalt chrome (cocr) rods that are part of the matrix system. the failure mode of the tips on the returned field products consisted of a brittle fracture of the proximal tip (i.E. the tip closest to the surgeon). the root cause was determined to be material strength and geometry of the initial design.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 042 01 16 000
  • Fecha de inicio del evento
    2016-01-12
  • 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=8763
  • 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
    Through a complaint investigation, it was discovered that the affected lots of the extraction screw could break or disassemble from the instrument. this may interfere with removal of the pfna and pfna-ii blade from the patient.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 138 07 16 000
  • Fecha de inicio del evento
    2016-07-21
  • 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=9722
  • 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 issue reported and confirmed is that the product labeling for this lot states the product lot is sterile, however there is also a statement on the product labeling which states "non-sterile". the product is mislabeled, the error is that the product labeling states "non-sterile". upon investigation of this report, deroyal confirmed that this product, isolation bag 30-5510, is required to be sterilized with ethylene oxide gas during the operational processes at deroyal prior to release.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 096 03 16 000
  • Fecha de inicio del evento
    2016-03-13
  • 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=4&rid=9017
  • 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
    We are notifying all dexcom customers that you may not receive an intended audible alarm or alert. as a result, if you rely on hearing the alarm or alert, you may not detect a severe hypoglycemic (low glucose) or hyperglycemic (high glucose) event.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 047 12 11 000
  • Fecha de inicio del evento
    2011-12-11
  • 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=1150
  • 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
    Patient support vertical brake hub rework ,the patient support can fall in an uncontrolled manner.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 056 11 18 000
  • Fecha de inicio del evento
    2018-11-20
  • 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=13504
  • 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
    Stago has informed that several customers have reported shortened (t1-t2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds for sta-control la2 have been observed (this range is specified on the kit value sheet). the subsequent root cause investigations have found that the issue is due to a sensitivity decrease which occurs towards the end of the respective lot number's shelf life. we have found this to be related to the material used for manufacturing the stoppers used only for the buffer and solvent vials. according to guidelines of the isth ssc anti phospholipids syndrome, several tests should be performed to detect and confirm the presence of la. hence, previously released patient results should not need to be re-assessed. there have been no reports of injury in relation to this issue.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 015 09 15 000
  • Fecha de inicio del evento
    2015-09-03
  • 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=5&rid=8183
  • 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
    The above mentioned reagent lots show a loss of sensitivity some months after production. the stated sensitivity cannot be guaranteed until the stated expiry date, which can lead to false negative results.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 091 07 18 000
  • Fecha de inicio del evento
    2018-07-18
  • 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=12928
  • 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
    Further to customer’s complaints, we have been able to confirm that the test sera anti-jka (ref. 104301) jka lots 17610.83.01, 17610.82.01 and 17610.81.01 shows a reduced reactivity potentially leading to false negative results, with some cells expressing a single dose of jka antigen jk (phenotype(a+b+)).
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 068 06 13 000
  • Fecha de inicio del evento
    2013-06-16
  • 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=3751
  • 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 some specific conditions, inconsistent grading between the results in the well/card and the results returned by the ih-1 000 may be observed. after deep investigations, confirm that in these very specific conditions, positive reactions might be read as negative by the system due to the analysis algorithm of the images. therefore, this issue might lead to a wrong result released to the host if all the 3 following conditions are met: 1. a result is returned as negative while the reaction is positive, dp, or requires a human interpretation . 2. this negative result is consistent with the global interpretation of the test. 3. the system is configured without the second reading function activated for all tests results.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 055 12 18 000
  • Fecha de inicio del evento
    2018-12-13
  • 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=4&rid=13615
  • 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 there are no wedge ids included in the dicom rt plan sent from the tps, the field in mosaiq will be created with no wedge.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 033 11 14 000
  • Fecha de inicio del evento
    2014-11-11
  • 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=6694
  • 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 ih-1000 software may lose the link sample/"test in progress". this loss might in the worst case lead to a mismatch between the test result and the sample.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 052 12 12 000
  • Fecha de inicio del evento
    2012-12-10
  • 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=2715
  • 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 case of not interpretable results in the anti-ab well (ab03) of id-cards intended for abo forward grouping, the ih-com software doesn't include the reaction of this well (result code -30) when sending the results to the laboratory host.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 069 05 13 000
  • Fecha de inicio del evento
    2013-05-20
  • 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=3624
  • 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 error relative to the liquid reagents management (test cells or anti-serum vials) might occur if the following conditions are present: 1. ih-1000 is in status "ready to start" and, 2. the user requests the unloading of a reagent rack while the system is creating the internal batch, the time slot during which the error could occur is about 2 seconds. 3. another rack is loaded immediately afterwards in the same position. if all three conditions are present, the ih-1000 may not use the full set of liquid reagents required to perform the tests of the ongoing batch. due to a software failure, the system may only use the vial placed in the first position of the re-ioaded rack for all the tests of the ongoing batch.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 112 04 12 000
  • Fecha de inicio del evento
    2012-04-28
  • 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=1743
  • 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 different patients (e.G. a & b) having the same first name, last name and date of birth are tested in the system, the data management system ih-com could merge the files of these patients even if patients id are used.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 155 06 12 000
  • Fecha de inicio del evento
    2012-06-27
  • 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=2019
  • 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
    Identified a trend of reactions weaker than expected when testing very weak samples on techno twinstation.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 058 08 14 000
  • Fecha de inicio del evento
    2014-08-12
  • 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=6282
  • 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
    Incorrect treatment when dicom exporting arcs using composite field sequencing.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 027 05 15 000
  • Fecha de inicio del evento
    2015-05-05
  • 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=7594
  • 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 recall is being conducted after the manufacturer internally has observed an unexpected result when using affected lot of dat igg-dilution id-card. during stability testing of the dat igg dilution id-card, the manufacturer's internal quality control team detected a decrease in the intensity of reaction for these two lots which could contribute to an underestimation of the danger of haemolysis for the patient.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 001 05 11 000
  • Fecha de inicio del evento
    2011-05-01
  • 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=363
  • 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: http://www.sfda.gov.sa/En/MedicalEquipments/recalls/NCAR+Brief.htm
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    The manufacturer has observed that test profiles on the ih-1000 analyzer, when id-diaclon anti-d is included, may generate incoherent results in the group of tests contained in the profile.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 008 09 14 002
  • Fecha de inicio del evento
    2014-10-20
  • 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=6602
  • 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
    Internal testing showed that with liaison tg (311861) lot 344161x an overestimation on thyroidectomized patient samples can be observed.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 060 08 14 000
  • Fecha de inicio del evento
    2014-08-12
  • 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=6284
  • 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
    Diasorin has become aware that the kit lots identified have a potential to produce an increased rate of positive results when used on liaison xl analyzer.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 112 03 12 000
  • Fecha de inicio del evento
    2012-03-31
  • 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=5&rid=1630
  • 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
    It may pose a safety risks to patients and users.
Notificaciones De Seguridad De Campo acerca de m2000sp Instrument
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    02503/08
  • Fecha
    2008-07-08
  • País del evento
    Germany
  • Fuente del evento
    BAM
  • URL de la fuente del evento
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/08/2008/02503-08_kundeninfo_en.html
  • Notas / Alertas
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
  • Notas adicionales en la data
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 144 05 17 000
  • Fecha de inicio del evento
    2017-05-28
  • 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=11106
  • 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
    Dorc became aware that the use of the 1363.Dd vfi pack for silicone oil syringes in combination with certain batches of 10m1 prefilled glass syringes containing silicone oil (i.E. sil-1000-s and sil-5000-s with expiry dates as of 2017-12) could result in breaking of the finger flange of the glass syringe, leaving the contents of the syringe (silicone oil) untouched.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 014 04 14 000
  • Fecha de inicio del evento
    2014-04-02
  • 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=5583
  • 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
    Dräger ceiling-mounted installations with monitor holder -the monitor can fall down if the monitor holder breaks -this problem concerns ondal ac 2000 spring-loaded arms shipped up until dec. 2006.
translation missing: es.activerecord.attributes.event.titles.recall_field_safety_notice
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 138 10 18 000
  • Fecha de inicio del evento
    2018-10-24
  • 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=13393
  • 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: BfArM
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    Possible loss of pressure in medical compressed air system due to leakage in compressed air conditioning unit medical air ensure.
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

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