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  • Dispositivo 3547
  • Fabricante 3547
  • Evento 3558
  • Implante 0
Retiro De Equipo (Recall) de VITROS Chemistry Products DGXN Slides; An in vitro diagnostic medica...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00658-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-02
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00658-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Ortho-clinical diagnostics, inc. (ocd) recently received complaints of elevated results using heparin plasma samples for vitros chemistry products dgxn slides. as a result of their investigation into these complaints, heparin plasma is being removed as a recommended specimen type for vitros dgxn slides.
  • Acción
    Laboratories are being advised to immediately discontinue using heparin plasma for VITROS DGXN Slides and to discuss previously reported results with the Laboratory Medical Director to determine appropriate course of action. Update your laboratory's Instructions for Use (IFU) Manual with the revised instructions that are provided with the recall notice.
Retiro De Equipo (Recall) de Eclipse Treatment Planning System (Radiation treatment planning syst...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00652-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-02
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00652-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    A software anomaly has been identified with the eclipse treatment planning system where changing the prescription in a calculated vmat or rapidarc plan may lead to monitor units which do not reflect the new prescription. if the dose prescription of a vmat or rapidarc plan is changed after the initial dose volume optimisation, the monitor units and dose distribution may not reflect the intended prescription.
  • Acción
    Varian is recommending users to implement work around instructions until a software fix is developed and implemented.
Retiro De Equipo (Recall) de Laryngoscope Handles (LED) and Laryngoscope Fibre Optic Blades; Lary...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00617-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-02
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00617-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The ‘cold soak disinfection’ section of the instructions for use requires the inclusion of a rinse step which is necessary post-disinfection with gluteraldehyde / cidex.
  • Acción
    IFU update
Retiro De Equipo (Recall) de Matrix Surgical Laparoscopic Spatula with cable (active endotherapy ...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00637-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00637-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer received a report that the insulation of a diathermy spatula appeared to have melted during use and that the patient sustained secondary site damage to their fallopian tube.
Retiro De Equipo (Recall) de Indirect (Closed-Tray) Transfer for Internal Hexagon (Used to create...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00672-3
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2012-07-05
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00672-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The external packaging label product description reads 'coping, transfer, waxing' instead of 'indirect (closed-tray) transfer for internal hexagon'.
  • Acción
    Quarantine and return affected stock to Zimmer
Retiro De Equipo (Recall) de STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - ...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00673-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-05
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00673-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer, asp, has determined that it does not have adequate data to support the entire duration of the product’s labelled shelf-life. as a result, the shelf life of sterrad cyclesure 24 biological indicator (bi) will be reduced by 9 months from the current expiry date on the product label.
  • Acción
    J&J; is asking customers to quarantine the affected lots that exceed the newly determined expiration date and return it to J&J.; Until the replacement stock is available, customers may continue to use the current inventory if it still has more than 9 month’s shelf life remaining. Product with labelled expiry date of May 2013 or later can be used.
Retiro De Equipo (Recall) de Elekta Monaco rel. 3.10.00 through 3.20.00 & Focal rel. 4.64.00 thro...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00670-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-05
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00670-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    If the dicom coordinates option is turned on in the reports pull down menu the following issues are seen on the resulting print out:issue 1: the coordinates will be in dicom space, thus not matching the setup reference dialogue.Issue 2: the shift coordinates are reported incorrectly. the z coordinate should become dicom negative y and the y coordinate should become dicom z.Incorrect shift coordinates are generated based on issue 2 above. these shifts can lead to incorrect patient positioning prior to treatment position verification.
  • Acción
    Customers to implement the work around instructions provided by the sponsor until the problem is resolved with the future release of a software patch. This action has been closed-out on 12/02/2016.
Retiro De Equipo (Recall) de Twinfix Ultra Ti Suture Anchor, 5.5mm (used to attach the end or end...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00678-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-05
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00678-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has advised that the distal part of the anchor may break on insertion into bone during surgery. the surgery may be completed using an alternative fixation device and, in most cases, the broken anchor can be retrieved with a grasper or sharp instrument.
  • Acción
    Quarantine and return affected stock to Smith & Nephew Surgical for replacement.
Retiro De Equipo (Recall) de Alginot (dental impression material); AlgiNot Cartridge Intro Kit; A...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00674-3
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2012-07-05
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00674-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The current instructions for use (ifu's) for alginot include product specifications and instructions that are not indicative of the actual performance of the product. more specifically, the ifu's incorrectly state the work time/mouth removal time.
  • Acción
    Kerr Australia is providing updated Instructions for Use (IFU)
Retiro De Equipo (Recall) de ABGII Modular Stems and ABGII Modular Necks (An exchangeable modular...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00493-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-06
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00493-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    This action is occurring worldwide because of a high incidence of wear, known as fretting and corrosion, at the join between the femoral stem and the neck component. fretting and corrosion can result in metal debris in and around the hip joint. if this occurs, patients may experience inflammation, adverse local tissue reactions (altrs), hypersensitivity/allergic reactions and osteolysis (bone loss).
  • Acción
    The ABGII Modular Femoral Stem and Modular Neck has been cancelled from the Australian Register of Therapeutic Goods (ARTG). Stryker Australia Pty Ltd has contacted orthopaedic surgeons who has ever implanted the ABGII modular hip replacement system. Those surgeons have been asked to contact their patients to discuss what clinical action is most appropriate. For more details, please see https://www.tga.gov.au/alert/abgii-modular-femoral-stem-and-modular-neck-hip-replacement-system and https://www.tga.gov.au/alert/abgii-modular-femoral-stem-and-modular-neck-hip-replacement-system-update .
Retiro De Equipo (Recall) de AcrySof CACHET Phakic Lens (Intraocular lens used for the reduction ...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00693-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-11
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00693-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    This is an update to the previous ‘urgent recall for product correction/hazard alert for surgeons’, dated 20th february 2012 (tga ref:rc-2012-rn-00145-3) issued by alcon, and is intended to further inform about an adverse event associated with the alcon acrysof cachet phakic lens and additional information gained through the studies allows an update to the directions for use (dfu). the updates to dfu are primarily associated with:– clarification that the lens is indicated for use for the correction of myopia between -6.0 d and -16.5 d.– additional information regarding the risk of acute endothelial cell loss (ecl) to strengthen communication of benefits and risks of implantation to the patient– clarification on the frequency of monitoring for ecl by specular microscopy– data on patients who experienced a greater than 30% endothelial cell loss (when compared to the preoperative cell count) and/or count below 1500 cells/mm² in the clinical studies.
  • Acción
    Customers to be aware of the updated safety information provided in the revised Directions for Use. Physicians are advised to follow the recommended post-operative follow-up schedule as outlined in the Hazard Alert letter.
Retiro De Equipo (Recall) de ULTRA Fabric Reinforced Surgical Gown, X- Large; MICROCOOL Breathabl...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00685-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-11
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00685-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Investigation identified variability occurring during the gown folding process which increased the thickness or height of the folded gown prior to packaging. the increased height of the folded gowns may cause the package seal to be compromised.
  • Acción
    Quarantine and return affected devices to Kimberly Clark.
Retiro De Equipo (Recall) de STERRAD 100S System Cassettes (To provide the hydrogen peroxide ster...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00697-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-11
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00697-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has discovered that printed information on the cassette results in the steriliser being unable to properly read the barcode. during the automated process used to print information on sterrad 100s system cassettes, an additional thirteenth (13th) bar was added to the barcode resulting in an unusable cassette. because the sterrad 100s system is designed to accept only properly coded cassettes, the sterrad 100s will reject all incorrect cassettes and display an error message: “incorrect cassette type”.
  • Acción
    Quarantine and return affected product to Johnson & Johnson Medical.
Retiro De Equipo (Recall) de Alaris PC Unit (General purpose infusion pump)
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00710-3
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-07-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00710-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has identified a potential risk associated with a component on the pc unit power supply board which is causing an error code (120, 4630) "system error" or "missing battery error" at start up or prevent programming changes if the problem occurs during use.
  • Acción
    If error observed remove PC unit from use. PC Unit boards replaced.
Retiro De Equipo (Recall) de Dimension RxL Reagent Management System (RMS) Power Cord Plug; An in...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00699-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00699-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Partial insertion of the power cord on the rms power input module can cause the plug to overheat and potentially create a fire hazard. dimension reagent management systems without a power cord retention clip may be affected.
  • Acción
    Siemens is providing work around instructions for users to implement until a permanent RMS power cord retention clip can be fitted.
Retiro De Equipo (Recall) de Premier C. difficile GDH - Positive Control Lot 6088.011, (Enzyme Im...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00702-3
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2012-07-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00702-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has received reports from customers that the positive control reagent is producing values close to or below the specified cut off of equal to or greater than 0.600, particularly when using automated instrumentation.
  • Acción
    Quarantine and dispose of any remaining affected product appropriately.
Retiro De Equipo (Recall) de CT1133S Cephalexin 100ug CL100 Antimicrobial Susceptibility Discs (U...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00694-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00694-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer's investigations confirmed that some cartridges within this batch may contain individual discs that are not sufficiently dosed with antibiotic. continued use of this lot could therefore result in false indication of resistance.
  • Acción
    Remove all affected lots from use and return to Oxoid Australia. This action has been closed-out on 02/02/2016.
Retiro De Equipo (Recall) de Portapres NiMh battery pack (Device to continuously measure blood pr...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00705-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-12
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00705-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Due to a production error the battery packs may become hot and start leaking when exposed to mechanical stress.This recall action was not notified to the tga before it was initiated by ptronik.
  • Acción
    The sponsor is providing work around instructions and replacing all affected battery packs.
Retiro De Equipo (Recall) de Mirage, Silverspeed, X-celerator & X-pedion Guidewires, Hyperform & ...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00717-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00717-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    There is a regulatory compliance issue where the guidewires were included in the australian register of therapeutic goods (artg) as class iia medical device. they should have been included as class iii. the hyperform and hyperglide occlusion balloon catheters, which are currently supplied in procedure packs also contain one of the above-mentioned guidewires. it has come to the attention of ev3 that these systems have not been included in the artg.
  • Acción
    Quarantine affected stock. The use of affected microcatheters should be only limited to patients eligible under the Special Access Scheme.
Retiro De Equipo (Recall) de Bowl Surgical Drape
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00709-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00709-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    There may be presence of foreign body particles on the drape material inside the packaging.
  • Acción
    Quarantine and return affected stock to De Fries Industries for replacement or credit note.
Retiro De Equipo (Recall) de Philips HeartStart MRx cardiac monitor / defibrillator
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00735-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00735-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Due to a corrupt data card some heartstart mrx defibrillator/monitors manufactured within these time periods may have incomplete 12-lead program files, and if so will present the following behaviour:- the device cannot analyse a 12-lead ecg report. due to this a user cannot view, print or transmit a 12-lead ecg.- a message 'cannot analyse ecg' is displayed on the mrx when an attempt to acquire a 12-lead report is made.
  • Acción
    User may continue to use an affected device, however the 12 lead report will not be generated, Philips Healthcare recommends have a back up device available. Philips Healthcare will be providing a software update to permanently correct the issue.
Retiro De Equipo (Recall) de 4.5mm Dyonics Bonecutter Electroblade (used during arthroscopic proc...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00730-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00730-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The manufacturer has advised that affected devices were labelled with an incorrect expiration date of 48 months instead of 36 months.
Retiro De Equipo (Recall) de Discovery Tray - Child and Small Sizes (A disposable foam tray used ...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00743-3
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2012-07-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00743-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Boxes of discovery trays marked to contain child-sized and small-sized trays actually contain adult-sized trays.
  • Acción
    Kerr Australia is asking users to return the affected products.
Retiro De Equipo (Recall) de Shiley Reusable Cannula Cuffed Tracheostomy Tubes
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00740-3
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-07-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00740-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Covidien has received customer reports on certain size 8 shiley reusable cannula, cuffed tracheostomy tubes that have had volume leakage and/or disconnection between the inner and outer cannulae. these events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed. if a leak and/or disconnection occur, ventilation may be adversely affected and the tracheostomy tube might require immediate replacement.
  • Acción
    Covidien is recalling affected stock and is providing phone advice concerning available alternatives.
Retiro De Equipo (Recall) de Brilliance series 6, 16, 40, 64, CT Big Bore, iCT and iCT SP (CT sys...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00739-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00739-3
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    In the ct systems listed, 16 bolts secure j-brackets which support the carbon table top to the couch subframe. philips healthcare received two complaints stating that the bolt heads of several of these sixteen bolts had broken off.
  • Acción
    Philips Healthcare is providing users with work around instructions and will be replacing the bolts on the affected systems to permanently fix the issue.
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