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  • Dispositivo 84
  • Fabricante 28
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de VISAGE PACS/CS
  • Tipo de evento
    Recall
  • ID del evento
    120833
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-02-10
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    During quality control and improvement process for visage 7 software two of specialized 2d measurement tools in some situations do not allow for manual pixel calibration and can lead to misleading results.
Retiro De Equipo (Recall) de FIXED FLANGE HYPERFLEX EXTRA LENGTH CUFFED TRACHEOSTOMY TUBE - SILICONE
  • Tipo de evento
    Recall
  • ID del evento
    120900
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2005-12-28
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    There can be a sporadic seal failure in the chevron seal portion of the pouch on some products causing the product to be non-sterile.
Retiro De Equipo (Recall) de VITROS ECI IMMUNODIAGNOSTIC INTACT PTH REAGENT PACK
  • Tipo de evento
    Recall
  • ID del evento
    120903
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-10-12
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Ortho confirmed that results obtained from vitros ipth reagent packs are positively biased (i.E. falsely elevated) compared to an alternative commercially available method. ortho observed a positive bias of 40% for samples with ipth concentrations <100pg/ml when testing with vitros ipth reagent packs in comparison to the roche elecsys pth test. ortho data demonstrated that this bias was consistent for all in-date lots.
Retiro De Equipo (Recall) de TITANIUM BUTTON PLATE
  • Tipo de evento
    Recall
  • ID del evento
    120984
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-18
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The depuy synthes button plate(s) were distributed with a package insert containing incorrect mr safety information that does not meet the current astm standard. in 2008 standard method astm f2503 standard practice for marking medical devices and other items for safety in the magnetic resonance environment was revised. the synthes button plate was labelled as mr safe per the astm standard metallic devices are no longer identified as mr safe.
Retiro De Equipo (Recall) de PLEURAFLOW CATHETER SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    120996
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-04-21
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Removal of product from distribution that exhibits possible vacuum/suction leaks. the leak is attributed to incomplete bond between the chest barb connection and the guide tube.
Retiro De Equipo (Recall) de INTERCEPT ORAL SPECIMEN COLLECTION KIT
  • Tipo de evento
    Recall
  • ID del evento
    121011
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-04-14
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Associated product technical bulletin mp-12-077 meets the canadian medical devices regulations definition for recall.
Retiro De Equipo (Recall) de EXCELSIOR AS TISSUE PROCESSOR
  • Tipo de evento
    Recall
  • ID del evento
    121012
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-01-22
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    A software bug has been identified where 248.5513 days after being switched on the thermo scientific excelsior as software switches from a positive to a negative count cycle.
Retiro De Equipo (Recall) de SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
  • Tipo de evento
    Recall
  • ID del evento
    121121
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2011-07-21
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Affected units may have a bearing malfunction that can cause inaccurate delivery of fluid including back flow over infusion and/or free flow. the pump may not issue an alarm when this occurs.
Retiro De Equipo (Recall) de ENGEN AUTOMATED SAMPLE HANDLING SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    121013
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-04-07
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Ortho clinical diagnostics (ocd) internal testing has confirmed instances where vitros 51 fs 4600 or 5600 systems allowed testing of multiple assays using a single urine specimen regardless of the pretreatment requirements for each selected assay potentially leading to biased patient results. urine samples for use with vitros ca mg and phos slides require acidification (pretreatment). the engen system software currently does not route these samples to the manual high priority exit location for pretreatment as intended. in addition the engen system software currently allows the ordering of invalid assay combinations that include urine samples with differing requirements with regard to pretreatment. depending upon the assay urine samples need to be acidified alkalized extracted or not treated prior to being processed on vitros systems.
Retiro De Equipo (Recall) de NON-STERILE STEP DOWN CONNECTOR
  • Tipo de evento
    Recall
  • ID del evento
    121020
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-12-05
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Integra lifesciences corporation (integra) has recently become aware that the current packaging configuration for the non-sterile step down connector may lead to a potentially conflicting message regarding product sterility. this individually sold non-sterile stepdown connector is packaged with a label that correctly states the product is non-sterile and also with instructions for use (ifu) from the sterile kit with which it is designed to be used as a reference to the customers. although the accessories are marked on the external label as non-sterile the ifu which is visible through the packaging states that the related shunt kit is sterile. this may lead to confusion as to whether these non-sterile products are sterile.
Retiro De Equipo (Recall) de DLP SINGLE STAGE VENOUS RETURN CANNULAE
  • Tipo de evento
    Recall
  • ID del evento
    121023
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-02-15
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Through internal investigation medtronic has identified the potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
Retiro De Equipo (Recall) de PANOCELL-10 FICIN TREATED REAGENT RED BLOOD CELLS
  • Tipo de evento
    Recall
  • ID del evento
    121026
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2001-09-04
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    They received and confirmed one report that thephenotype of the cells in vial #5 (untreated) were the same as the cells in vial #4 (untreated).
Retiro De Equipo (Recall) de PHADIA 250 SYSTEM - INSTRUMENT
  • Tipo de evento
    Recall
  • ID del evento
    121077
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-12-01
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Erroneous results may occur as a result of a software issue when specific conditions occur with the phadia 250. the issue can occur with all versions of the phadia prime software up to and including version 2.1.4. the issue will cause software to disregard default dilution factors for rejected samples when using the "ok to all" function for retesting of samples if specific criteria are met.
Retiro De Equipo (Recall) de GEMINI VOLUMETRIC INFUSION PUMPS/CONTROLLERS
  • Tipo de evento
    Recall
  • ID del evento
    121087
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1997-06-11
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
Retiro De Equipo (Recall) de DIMENSION VISTA SYSTEM PROT1 CON
  • Tipo de evento
    Recall
  • ID del evento
    121090
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-10-28
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics has confirmed that control vlaues prot1 con h may be found out of range ( >+/- 15%) for dimension vista prealb flex reagent cartridge leading to invalid runs. we have no indication that other analytes in prot1 con h are affected by this issue.
Retiro De Equipo (Recall) de HALL ULTRAPOWER SURGICAL DRILL SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    121126
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2004-08-27
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Outer pouch may not be completely sealed below the pouch thumbnotch area thereby potentially compromising the sterility of the device.
Retiro De Equipo (Recall) de BIOHORIZONS .050 ONE-PIECE HEX DRIVER
  • Tipo de evento
    Recall
  • ID del evento
    121151
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-04-17
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Specific lot numbers of the .050 one-piece hex driver (135-351) may not engage properly. this may make it difficult to tighten or loosen compatible biohorizons components such as abutment screws coping screws and healing abutments.
Retiro De Equipo (Recall) de ONE TOUCH SURE STEP BLOOD GLUCOSE MONITORING SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    121186
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-03-13
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Potential for missing segments on the meter lcd display which could cause blood glucose results to be misinterpreted.
Retiro De Equipo (Recall) de FLOW DEPENDANT MICRO-CATHETER W/PROGRESSIVE SUPPLENESS
  • Tipo de evento
    Recall
  • ID del evento
    121187
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-02-24
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    The puncture of the distal tube by the mandrill which is not completely inserted in the catheter.
Retiro De Equipo (Recall) de PERSONA THE PERSONALIZED KNEE SYSTEM - TIBIAL SIZING PLATE
  • Tipo de evento
    Recall
  • ID del evento
    121192
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-08-15
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Potential for intermittent cracks in the raw material batch used to produce the affected products.The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Retiro De Equipo (Recall) de HOMECHOICE PRO AUTOMATED PD SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    121193
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-02-19
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Baxter corporation is initiating a product recall for one (1) specific serial number of homechoice pro automated pd system because of a shipping/receiving error at baxter's third party logistics provider that led to an unreleased device being shipped to one (1) customer.
Retiro De Equipo (Recall) de AESTIVA/5
  • Tipo de evento
    Recall
  • ID del evento
    121195
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-02-12
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    A potential leak in the breathing system under specific circumstances in which the seal on the main system manifold becomes unseated.
Retiro De Equipo (Recall) de VENTURE CATHETER
  • Tipo de evento
    Recall
  • ID del evento
    121196
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-05-03
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Potential for excess material to separate from catheter during procedure.
Retiro De Equipo (Recall) de IMMULITE SYSTEM - TOTAL T3 ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    121403
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2000-06-30
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Reports of unexplained elevations in patient results.
Retiro De Equipo (Recall) de ABX PENTRA 400 CLINICAL CHEMISTRY SYSTEM - MAGNESIUM RTU ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    121359
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-09-26
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Potential that customers running the magnesium rtu assay on the abx pentra 400 chemistry analyzers that on-board stability has been updated. user will be unable to calibrate the magnesium rtu assay after 1 day of on-board (on instrument use) the control will be out of range at values lower than target values. the result reported using this failed calibration will be flagged "cal_error" displayed on the results with a "c".
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