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  • Dispositivo 12
  • Fabricante 10
  • Evento 124969
  • Implante 5
Retiro De Equipo (Recall) de INTER-OP ACETABULAR SYSTEM- HEMISPHERICAL POROUS SHELL W/SEALED SCRE...
  • Tipo de evento
    Recall
  • ID del evento
    19417
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2000-12-20
  • 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 KRYPTONITE BONE CEMENT
  • Tipo de evento
    Recall
  • ID del evento
    18646
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-05-03
  • 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
    Recent testing has confirmed that strength and stiffness of the bone cement decreases by approximately half when the testing is conducted at body temperature. preclinical testing was conducted at ambient temperature.
Retiro De Equipo (Recall) de DIMENSION CLINICAL CHEMISTRY SYSTEM - BUN/UREA NITROGEN
  • Tipo de evento
    Recall
  • ID del evento
    18655
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2008-01-18
  • 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
    Inaccurate results with bun flex cartridge lot fc8283.Only a portion of the lot is affected and not all wells within an affected unit.Test results may be falsely elevated or depressed variably up to 34%.
Retiro De Equipo (Recall) de SARNS D4 CUSTOM AORTIC ARCH CANNULA
  • Tipo de evento
    Recall
  • ID del evento
    18656
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1996-07-04
  • 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
Retiro De Equipo (Recall) de SELF-DRILLING SCHANZ SCREW
  • Tipo de evento
    Recall
  • ID del evento
    18667
  • Clase de Riesgo del Evento
    III
  • 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 raw material did not meet the specifications.
Retiro De Equipo (Recall) de IMMULITE 2000 SYSTEM - GI-MA ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    18668
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-02-13
  • 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
    Siemens healthcare diagnostics has confirmed a positive bias with the bio-rad lyphochek tumor marker plus control and the bio-rad liquichek tumor marker control when used with immulite 2000/immulite 2000 xpi gi-ma (ca19-9) assay kit lots 312 and 313. in addition a greater than expected change in patient sample recovery may be observed when moving from kit lot 311 to kit lots 312 and above. while recovery with patient samples for individual kit lots continues to meet siemens quality control release specification kit lot 311 was observed to perform at the lower end of the specification and kit lot 312 at the upper end of the specification resulting in a greater than expected difference between these two kit lots.
Retiro De Equipo (Recall) de PRIMARY ADDITIV ADMINISTRATION SETS WITH CHECK VALVE
  • Tipo de evento
    Recall
  • ID del evento
    18669
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-01-16
  • 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
    1)the referenced sterile sets with a particular configuration drip chamber could possibly leak. 2) and possibly have the attached tubing disconnect from the drip chamber.
Retiro De Equipo (Recall) de ARCHITECT "I" SYSTEM - HIV AG/AB COMBO ASSAY (DONOR SCREENING)
  • Tipo de evento
    Recall
  • ID del evento
    18684
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2009-12-18
  • 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 calibrator values for architect hiv ag/ab combo calibrator are decreasing over time which leads to out of range high control values and/or invalid calibration due to control(s) out of range. testing of all non-expired calibrator and control lots indicates no other lot is affected by the quality issue.
Retiro De Equipo (Recall) de PICCOLO XPRESS SYSTEM - LIPID PANEL PLUS
  • Tipo de evento
    Recall
  • ID del evento
    18703
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-10-25
  • 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
    Lipid plus panel plus reagent discs for the abaxis piccolo xpress chemistry analyzer.
Retiro De Equipo (Recall) de PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
  • Tipo de evento
    Recall
  • ID del evento
    18709
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-09-12
  • 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
    Abbott is advising physicians that our company is aware of instances in which the elective replacement indicator (eri) in some devices has triggered earlier than intended. in these cases the eri alerts were triggered early due to an error in how the device calculates the actual remaining battery life in the impacted implantable pulse generators (ipg). abbott avise les medecins qu'elle a connaissance de cas ou l'indicateur de remplacement electif (ire) de certains dispositifs s'est active plus tot que prevu. dans ces cas l'ire s'est active de facon hative en raison d'une erreur dans la maniere dont le dispositif calcule la duree de vie restante reelle de la pile dans les generateurs d'impulsions electriques implantables (giei) concernes.
Retiro De Equipo (Recall) de MOBIMED SYSTEM - HOSPITAL WORKSTATION
  • Tipo de evento
    Recall
  • ID del evento
    18716
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2010-10-28
  • 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
    When the system configuration of the clinical workstation is set to averaging ecg as the start-view the area showing averaging ecg is not re-drawn until new valid data is received. this field can then contain data from a previous patient.
Retiro De Equipo (Recall) de SYSMEX BLOOD COAGULATION ANALYZER CA-540
  • Tipo de evento
    Recall
  • ID del evento
    18726
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2005-07-22
  • 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
    Manufacturer has found an issue when using the akima method of calculating the standard curve. a change to the standard curve method for this assay is needed.
Retiro De Equipo (Recall) de REAGENT RED BLOOD CELLS REFERENCELLS A1 A2 B&O
  • Tipo de evento
    Recall
  • ID del evento
    18732
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2005-04-29
  • 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
    Some vials of the a1 and b cells for these lots have a hematocrit value between 4% and 6% which is higher than the expected range of 2-4%.
Retiro De Equipo (Recall) de PLUM XL 3 MICRO/MACRO INFUSION SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    18734
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-03-03
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
  • Causa
    Hospira has received complaints for the plum xl infusion pumps related to no audible alarm conditions. users reported that during an alarm condition the pump displays a visual alarm but the alarm buzzer does not audibly sound.
Retiro De Equipo (Recall) de PARADIGM QUICK-SET INFUSION SETS
  • Tipo de evento
    Recall
  • ID del evento
    18735
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2013-06-13
  • 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
    Medtronic has become aware of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the connector on medtronic paradigm infusion sets. this recall also provides information on how to prevent this from occurring. exposure of the inside of the tubing connector to fluid is most likely to occur if insulin is spilled on the top of the insulin reservoir when the reservoir is removed from the transfer guard after filling the reservoir from a vial of insulin. if this occurs the insulin can temporarily block the vents in the connector that allow the pump to properly prime. if these vents are blocked this can potentially result in too much or too little insulin being delivered which may cause hypoglycemia or hyperglycemia which in extreme cases may cause loss of consciousness or death.
Retiro De Equipo (Recall) de INTELLIVUE - INFORMATION CENTER
  • Tipo de evento
    Recall
  • ID del evento
    18736
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-04-06
  • 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 is a potential for early component failure. the system board in the hewlett-packard rp5700 computer contains electrolytic capacitors that may fail prematurely causing the computer to malfunction. it is also possible that the display may "freeze".
Retiro De Equipo (Recall) de INNOVA IGS 540 IMAGE GUIDED SYSTEM - MAIN UNIT
  • Tipo de evento
    Recall
  • ID del evento
    18738
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-04-18
  • 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
    While performing a fluoroscopic examination on the innova systems there is a potential of nonrecoverable loss of imaging modes with no advance warning due to a relay failure in the power distribution box (pdb).
Retiro De Equipo (Recall) de ACL FUTURA/ADVANCE ANALYZER - CLASS 2
  • Tipo de evento
    Recall
  • ID del evento
    18747
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    1997-06-20
  • 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 RAYSTATION
  • Tipo de evento
    Recall
  • ID del evento
    18753
  • Clase de Riesgo del Evento
    II
  • 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
    This notice concerns a problem with the computation of roi voxel volumes for cases where the ct has variable slice spacing. the dose grid volumetric representation of an roi can be wrong. this affects all dose-volume properties for such rois including dvh dose statistics clinical goals and constraints or objective functions. furthermore if material override rois are used or if the external is not represented by contours the bug can trigger an error in the 3d dose distribution.
Retiro De Equipo (Recall) de ELECSYS PTH (PARATHYROID HORMONE)
  • Tipo de evento
    Recall
  • ID del evento
    18757
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2007-05-02
  • 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
    Following internal testing mfr has identifird that hemoglobin can interfere with the elecsys pth assay at value higher than 0.0932 mmol/l or 0.15 g/dl.
Retiro De Equipo (Recall) de MEDI LIFTER III
  • Tipo de evento
    Recall
  • ID del evento
    18758
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2004-04-14
  • 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
    Le support de l'actuateur s'est detache du mat causant la chute du patient.
Retiro De Equipo (Recall) de ONCOR IMPRESSION IMRT PLUS
  • Tipo de evento
    Recall
  • ID del evento
    18759
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-03-27
  • 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
    As a result of investigation into complaints related to the treatment table (txt) that is part of the linear accelerators the following safety issues were identified: 1. in very rare instances the actual table position may significantly deviate from the position at the table side control and the linac control console but no interlock occurs. 2. in sporadic cases the following issue for the table axis lateral longitudinal and isocentric rotation occurs: after a manual table movement with released brake an immediate automatic movement for the same table axis is not possible.
Retiro De Equipo (Recall) de 3 WHEEL ROLLATOR WALKER WITH BASKET TRAY AND POUCH
  • Tipo de evento
    Recall
  • ID del evento
    18760
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-07-21
  • 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
    Drive medical canada inc received a report of an injury associated with the deluxe 3-wheel rollator. upon a full investigation it was determined that the maintenance of all of the nuts and bolts was not followed. further investigation revealed that the user's manual did not specify this aspect for on-going use for the rollator.
Retiro De Equipo (Recall) de OMNILAB V.12.0 - LABORATORY INFORMATION SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    18761
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2013-05-28
  • 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
    Lors d'une validation effectuee par un client sur un environnement de formation il a ete constate qu'une requete initialement associee au patient a s'est retrouvee associee au patient b et qu'une requete associee au patient c s'est retrouvee associee au patient b.
Retiro De Equipo (Recall) de FUJI SYNAPSE IMAGE & INFORMATION MANAGEMENT SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    18762
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-03-06
  • 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 image orientation and the orientation markers(s) and annotations no longer match when the fuji ct image processing algorithm is applied after rotating or flipping a ct image.
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