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  • Dispositivo 25
  • Fabricante 5
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Colleague Volumetric Infusion Pumps
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00384-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-31
  • 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-2014-RN-00384-1
  • 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
    During 2011, it was identified that a quantity of pumps fitted with two ceramic 1.6a slow-blow fuses in the rear housing was failing prematurely. investigation led to a change of the fuse type fitted during future manufacture and service, from a ceramic fuse to a glass fuse, which has a different rupture characteristic. the failure rate of this reported issue has subsequently declined following the replacement with a glass fuse in newly manufactured pumps. if the fuses fail the device cannot charge the batteries even when connected to a.C. power. failure of the fuses while the pump is in operation would result in the pump switching from a.C. power to battery power and the a.C. icon would extinguish. the pump would continue to run on battery power with corresponding battery discharge alarms.
  • Acción
    Customers are asked to examine the two fuses installed in the rear of the pump which can be accessed by slotted fuse covers to establish if the fuses are glass or ceramic type. Ceramic fuses should be replaced with the glass fuses which will be supplied by Baxter. For Baxter owned pumps placed with customers, Baxter will carry out this activity at the next service.
Retiro De Equipo (Recall) de Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM,...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00385-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-03
  • 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-2014-RN-00385-1
  • 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
    Gradient coil electromechanical connections may loosen causing an increase in resistance. the increased resistance can lead to increasing heat during scanning which, in turn, can cause material in the rear endbell enclosure to overheat, generate smoke in the scan room, and cause some localised melting of the endbell. this overheating has occurred only while units were being serviced by ge service engineers during repeated evaluation scanning. however, the issue could also occur in clinical mode.
  • Acción
    While in clinical mode, If the operator is notified via user interface message that there are multiple X, Y, or Z gradient distortion faults they should monitor for smoke odours or evidence of overheating. If they detect either a smoke odour or evidence of overheating they should stop scanning immediately, remove the patient and call their GE Healthcare Service Representative. Scanning should not resume until the GE Healthcare service representative has confirmed the MRI scanner is functioning normally. GE Healthcare will correct all affected products.
Retiro De Equipo (Recall) de OEC 9900 Workstation Monitor Spring Arm ScrewsAll OEC 9900 systems m...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00389-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-02
  • 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-2014-RN-00389-1
  • 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 screws that attach the workstation monitor spring arm to the extension arm may fail, causing the spring arm and monitor to fall forward.
  • Acción
    A GE HealthCare Field Engineer will replace the screwS to ensure that the system is operating safely and meets all specifications. Until the correction is complete, end users are advise to use caution when positioning or extending the arm. In addition, refrain from positioning staff or patients directly underneath or in front of a work station monitor.
Retiro De Equipo (Recall) de Fraxel Dual 1550/1927 Laser Systems
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00402-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-03
  • 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-2014-RN-00402-1
  • 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
    Solta medical australia has determined that some customers may have obsolete versions of fraxel dual laser labelling (user manual and treatment settings card).The two obsolete documents incorrectly provided parameter settings for the treatment of melasma using the 1927 nm wavelength laser. only the 1550 nm wavelength has approved indications for use for the treatment of melasma.While both issues were corrected prior to 27 october, 2010, customers may not have received a corrected version of the labelling.-revision a of the 10-05170 re: store dual user manual, released on 27 august,2009 incorrectly stated the 1927 nm laser was indicated for melasma.This was corrected on revision b of 10-05170. -mk 3100 revisions a and b, fraxel re: store dual laser treatment settings card, effective from 2nd december 2009 - 27th october 2010 incorrectly stated the 1927 nm laser was indicated for melasma.This error was corrected on revision c of mk 3100.
  • Acción
    Solta Medical Australia is requesting their customers to return affected versions of the User Manual or Treatment Settings Card. Replacement information will be provided to customers.
Retiro De Equipo (Recall) de Cadisc-L Total Disc Replacement Device
  • Tipo de evento
    Recall
  • Fecha
    2014-11-24
  • País del evento
    Lebanon
  • Fuente del evento
    RLMPH
  • URL de la fuente del evento
    https://www.moph.gov.lb/userfiles/medical_care/Cadisc.pdf
  • Notas / Alertas
    Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de Monitor AC2000 Spring Arm
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00406-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-07
  • 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-2014-RN-00406-1
  • 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
    Draeger medical australia has been informed of three cases where a welded seam in the spring-loaded arm of the monitor holder broke resulting in the monitor falling. although no injury has been reported, the risk of injury to persons positioned beneath the monitor cannot be excluded.
  • Acción
    A Drager service representative will inspect all potentially affected spring-loaded arms. A replacement arm will be provided for all devices determined to be affected.
Retiro De Equipo (Recall) de Kenex suspension arm with radiation shield and/or surgical lamp
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00407-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-04
  • 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-2014-RN-00407-1
  • 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
    Ge healthcare has recently become aware of an improper installation of the kenex suspension arm of a radiation shield. the suspension arm was not installed by ge healthcare per specified installation requirements. there is no deficiency associated with the kenex suspension arm. there has been one reported incident of a radiation shield falling from the ceiling causing a minor injury.
  • Acción
    GE Healthcare is inspecting all affected systems to verify that the Kenex suspension radiation shields and surgical lamps are properly installed. A GE representative will contact customers to arrange for the inspection. Any affected systems will be corrected.
Retiro De Equipo (Recall) de Vivid E9 Ultrasound Systems, software versions 113.0.1 to 113.0.5 wh...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00411-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-04
  • 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-2014-RN-00411-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue where the probe power surveillance settings for 4 probes (c1-5-d, c2-9-d, ic5-9-d and m5sc-d) are incorrect. this may result in a situation where probes can overheat. if a certain specific hardware failure occurs on the vivid e9 transmitter board (gtx192) this may, in combination with the incorrect power surveillance settings mentioned above, result in an overheating of the probe surface on the listed probes. no overheating of the probes listed above has been reported.
  • Acción
    GE is requesting their customers to cease using the IC5-9-D probe until the systems have been corrected. If any other prodes are observed to be over heating customers should discontinue using the Vivid E9 system and contact GE immediately.
Retiro De Equipo (Recall) de VITROS Chemistry Products Specialty Diluent and VITROS Chemistry Pro...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00413-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-07
  • 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-2014-RN-00413-1
  • 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 confirmed reports of lower than expected c-reactive protein (crp) results when using the affected lots of vitros specialty diluent and vitros fs diluent pack 3 to dilute samples tested on vitros crp slides. internal testing determined that results using vitros crp slides may be negatively biased by approximately 51% using a 3x dilution factor.
  • Acción
    Ortho Clinical Diagnostics is requesting their customers to discontinue use and discard any remaining stock from the affected lots of diluent. Replacements from unaffected lots are available. This action has been closed-out on 11/04/2016
Retiro De Equipo (Recall) de enGen Laboratory Automation Systems configured with Data Innovation,...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00414-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-07
  • 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-2014-RN-00414-1
  • 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 engen laboratory automation system is an automated track which integrates clinical analysers and the customer’s lis (laboratory information system). it centrally controls pre-analytical and post-analytical processing as well as sample transport to multiple independent analysers and devices. ortho clinical diagnostics (ocd) internal testing has determined that when a sample requires follow-up action, such as dilution or retesting due to a mechanical issue, it is possible for that sample to be routed to the sample storage drawer (storage) prior to the completion of the necessary pending action. a delay in patient test result(s) reporting could occur.
  • Acción
    Laboratories are advised to manually rerun samples that have been prematurely stored. A software modification is currently in development and will be provided once complete. This action has been closed-out on 11/02/2016.
Retiro De Equipo (Recall) de Pipeline Embolization Device and Alligator Retrieval Device
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00415-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-04
  • 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-2014-RN-00415-1
  • 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
    Through internal testing, covidien identified certain lots of the pipeline embolization device and the alligator retrieval device that have the potential for the ptfe (polytetrafluoroethylene) coating on the delivery wire to delaminate and detach. there have been no patient injuries reported.
  • Acción
    Covidien is requesting hospitals to discontinue use of the devices and segregate from other inventory. Covidien will arrange for the pick-up and return of the affected devices. This action has been closed-out on 10/02/2016.
Retiro De Equipo (Recall) de Dynabeads HLA (Human Leucocyte Antigen) Class II (an in vitro diagno...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00416-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-08
  • 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-2014-RN-00416-1
  • 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 of dynabeads hla class ii, life technologies as, advises that the listed lots have decreased antibody performance and may not isolate sufficient levels of hla class ii cells required for further testing. lot 142281200 is still within specification, however testing has indicated that it might lose reactivity prior to its expiry date.
  • Acción
    Life Technologies is requesting their customers to inspect their stock and dispose of all units from the affected lots. Lot 142281200 can continue to be used until replacement stock is available.
Retiro De Equipo (Recall) de Philips Ingenuity Core128 with Software Version 3.5.5 (whole body Co...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00417-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-07
  • 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-2014-RN-00417-1
  • 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
    An issue has been found with the ingenuity core128 system with software version 3.5.5. if additional acquisitions/scans are requested prior to completion of the current reconstructions, not all planned images from the current reconstruction are displayed to the user. users may not be aware the information is not lost, as the raw data can be reconstructed off-line displaying all requested reconstructions. if a rescan is required, there is potential for unnecessary radiation.
  • Acción
    Philips is requesting customers to verify that all planned image reconstructions are completed and to perform off-line reconstructions, if expected images are missing. Philips will be installing a software update to correct the issue. This action has been closed-out on 01/02/2016.
Retiro De Equipo (Recall) de ICS G2 Clinical Access (used for acquiring 24-72 hours of standard p...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00418-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-04-07
  • 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-2014-RN-00418-1
  • 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 defect in the ics g2 clinical access software cd. the programs installed on the clinical access cd are incorrect and will prevent the user from installing clinical access.
  • Acción
    Medtel Australia is requesting their customers to dispose of CD: PN 063-1829-11 Rev A and replace with Rev B. The replacement CD will be delivered to all relevant departments of the hospital by a Medtel service engineer.
Retiro De Equipo (Recall) de Cavafix (used for the catheterisation of vena cava)
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00419-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-08
  • 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-2014-RN-00419-1
  • 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 course of internal quality checks the manufacturer discovered that aging of these products can result in deposits of particles on the surface of the catheters. to date, no harm or any other adverse patient outcome which could be associated to the above described observation has been reported to b. braun melsungen ag.
  • Acción
    B.Braun is requesting their customers to inspect their stock and quarantine any units from the affected batches. All affected stock will be recovered by B.Braun and a credit note issued. This action has been closed-out on 29/01/2016.
Retiro De Equipo (Recall) de Therapy, traction equipment. YUNO extension device
  • Tipo de evento
    Recall
  • ID del evento
    25940/1/13
  • Fecha
    2013-08-05
  • País del evento
    Lebanon
  • Fuente del evento
    RLMPH
  • URL de la fuente del evento
    https://www.moph.gov.lb/userfiles/medical_care/25940-1-13.pdf
  • Notas / Alertas
    Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de ACUSON X700 Ultrasound System with software versions 1.0.00, 1.0.01,...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00420-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-08
  • 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-2014-RN-00420-1
  • 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
    When foursight 4d ultrasound imaging, 3-scape real-time 3d imaging, or anatomical m-mode are used during an obstetric or gynecology studies, the following data from the previous patient could replace the current patient's data in the report:- clinical lmp (last menstrual period)- clinical edc (estimated date of confinement)- clinical ma (menstrual age)- indicationif the replaced data is not noticed, there is a potential risk of performing additional diagnostic or non-indicated therapeutic procedures.
  • Acción
    To avoid this scenario, the following steps are recommended by Siemens: - Always review the patient report at the end of each study and confirm the report contains only measurements and patient data relevant to the exam just performed. - Before exiting fourSight 4D ultrasound imaging or 3-Scape (3D) imaging access and review the patient report. This step refreshes the data in the report. A new version of software resolving the error will be implemented in the affected units.
Retiro De Equipo (Recall) de Potassium 10mmol in 0.225% Sodium Chloride and 10% Glucose (500ml)
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00421-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-08
  • 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-2014-RN-00421-1
  • 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
    Baxter healthcare is issuing a recall as a result of a complaint received indicating that the labelling of this product contains an error. underneath the “potassium 10 mmol” type on the main label, there is bracketed text that states “potassium chloride 0.075%”. the figure of 0.075% is incorrect. the correct figure should be 0.15%.
  • Acción
    Hospitals are requested to remove all units from affected lots. The affected product should be returned by contacting Baxter Healthcare Customer Service. Baxter is requesting prescribers to monitor patients infused with the affected product for any irregularity in electrolyte levels.
Retiro De Equipo (Recall) de Edwards Lifesciences Fem-Flex II Cannulae
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00422-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-09
  • 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-2014-RN-00422-1
  • 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
    Edwards lifesciences has received five complaints globally in the last four months involving the separation of dilator tips on specific models of fem-flex ii arterial cannula sizes 16, 18 and 20 french. some of the reported events involved separation of the tip of the dilator and required retrieval through an interventional radiologic procedure.
  • Acción
    Edwards is requesting hospitals to quarantine and return the affected devices immediately.
Retiro De Equipo (Recall) de Lipase Reagent (diagnostic good for the quantitation of lipase in hu...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00423-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-09
  • 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-2014-RN-00423-1
  • 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 lipase reagent package insert for the lots above has incorrect information regarding the required cuvette smartwash for triglyceride. the insert indicates that the triglyceride cuvette smartwash assay parameter is not required on architect system software version 7.00 or higher; however, the triglyceride smartwash is required for the lipase assay on all software versions. the insert is correct beginning with lot 45200uq12.
  • Acción
    End users are advised to verify that Lipase assay parameters on ARCHITECT cSytems are configured for a Trig (Trigylceride) Cuvette SmartWash with 345 volume of 10% Detergent B. If the Lipase SmartWash for Trigylceride is not configured, immediately update the parameter by adding a Trig (Trigylceride) Cuvette SmartWash with 345 volume of 10% Detergent B. Thia action has been closed on 28/01/2016.
Retiro De Equipo (Recall) de LenSx Laser System (used for femtosecond cataract surgery)
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00424-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-10
  • 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-2014-RN-00424-1
  • 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
    Alcon is addressing reports of unexpected downward motion of the gantry. these reports are associated with systems manufactured with an older style motor/brake assembly. a new style motor/brake assembly (current version) has been used in manufacturing since may 2012. of the 41 reports, contact with the patient's eye or face was reported in three instances. in all of these cases, the contact with patient eye resulting from the unexpected downward gantry motion did not lead to a serious injury or a serious deterioration in state of health.
  • Acción
    If customers experience any unexpected gantry movement, they are advised to immediately notify Alcon and stop using the LenSx Laser System. Alcon will replace and install the current motor/brake assembly on any impacted LenSx Laser System manufactured prior to May 2012, including those that have not been previously upgraded.
Retiro De Equipo (Recall) de syngo Dynamics v9.5 with Sensis-syngo Dynamics Integration (Radiolog...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00425-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-17
  • 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-2014-RN-00425-1
  • 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
    Sensis reference numbers greater than 1,000,000 are wrongly modified during transfer to syngo dynamics. in this case during “in-progress” a study will get a sensisrefno for the wrong study in sensis. this will cause an incorrect link between syngo dynamics images and the sensis study data. when a patient study is opened in syngo dynamics a sensis report of another patient study is shown.The preconditions for this to occur are:- sensis-syngo dynamics integration- sensis study is opened from syngo dynamics while still "in progress"- sensis reference number is > 1000,000this could result in patient mismatch or a persistent unintended change to patient data could result. the patient mismatch is detectable when the study is opened for the first time if the toolbar is not configured to auto-hide.
  • Acción
    Siemens is preparing a service patch modification that will resolve the potential malfunction. In the interim, end users are requested to discontinue opening "in progress" studies and to configure the “AXIOM Artis AE” title in syngo Dynamics to "Other" type of station. This action has been closed-out on 02/02/2016.
Retiro De Equipo (Recall) de MEDRAD Continuum Infusion PumpSystems ditributed prior to March 2008
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00426-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-04-11
  • 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-2014-RN-00426-1
  • 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
    Bayer healthcare is recalling brackets used to mount the continuum pump on the iv pole distributed with non-wireless versions of medrad continuum mr infusion systems prior to march 2008. these brackets are being recalled because of a potential safety risk in the mri environment associated with locking pins which may become damaged and not restrain the pump from being attracted to the mri magnet.
  • Acción
    Imaxeon is requesting their customers to inspect their bracket immediately. If a bracket has a damaged pin end users are advised to cease use immediately and remove from the MR scan room. Undamaged brackets should be inspected every time a Continuum Pump is installed or removed until a replacemnt bracket is supplied.
Retiro De Equipo (Recall) de EverCross .035" OTW PTA Catheter (Balloon dilatation angioplasty cat...
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00431-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-10
  • 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-2014-RN-00431-1
  • 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 is conducting a recall of two production lots of the evercross 0.035 pta balloon catheter because of a product labelling error. based on customer reports and covidien's internal investigation, it has been identified that there is a discrepancy in the pta balloon length and the delivery catheter length printed on the product labelling.
  • Acción
    Customers are advised to immediately discontinue the use of the affected device and segregate this product from other inventory for returning to Covidien
Retiro De Equipo (Recall) de Extension Tubing in Refill Kits for use with Synchromed pumps
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-00432-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-11
  • 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-2014-RN-00432-1
  • 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
    Medtronic australasia pty limited is initiating a voluntary recall for a specific lot of our model 8551 refill kits. medtronic have identified that some refill kits in the affected lot may contain an extension tubing set that is occluded. healthcare professionals may be unable to aspirate or fill the synchromed pumps using one of these affected refill kits.
  • Acción
    Medtronic is requesting their customers to identify and segregate devices from the affected lot. Return of stock will be organised by Medtronic Customer Service.
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