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  • Dispositivo 4
  • Fabricante 2
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de CARDIAC TROPONIN T FOR COBAS H 232
  • Tipo de evento
    Recall
  • ID del evento
    57463
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-12-23
  • 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
    Incorrect lot number printed on the outer packaging of the cardiac control troponin-t kit. printed lot number is: 173 934-03 and correct lot number is: 176 934-03.
Retiro De Equipo (Recall) de IMMULITE SYSTEM - TOTAL IGE ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    57467
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2001-11-11
  • 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
  • Causa
    An assembly error resulted in a low percentage of test units from these kit lots not containing a coated bead.
Retiro De Equipo (Recall) de BECKMAN COULTER AU2700 IMMUNOCHEMISTRY SYSTEM ANALYZER - CLASS 2
  • Tipo de evento
    Recall
  • ID del evento
    57486
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2007-11-27
  • 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
    Concordance error. mechanical abnormality in the rack caused the rack to advance to position 3 instead of 1 resulting in concordance errors. user manual does not address this error.
Retiro De Equipo (Recall) de AEROSET SYSTEM - MAGNESIUM ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    57508
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-08-07
  • 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
    Manufacturer has received reports of magnesium test results with an upward shift from 0.4 meq/l to 2.1 meq/l and can delay treatment for low levels of magnesium.
Retiro De Equipo (Recall) de DISPOSABLE GLASS TIP FOR DERMABRADER
  • Tipo de evento
    Recall
  • ID del evento
    57510
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2001-12-14
  • 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
    Some tips had an internal sharp edge caused by moulding burrs. possibility that redness on the skin from too strong a dermabrasion treatment by an inexperienced operator could occur.
Retiro De Equipo (Recall) de KOLIBRI SYSTEM - STATION
  • Tipo de evento
    Recall
  • ID del evento
    57513
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-08-19
  • 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
    For the spectra camera interfaces assembled within the kolibri mobile camera stand a long-term reliable fixation of the camera unit cannot be guaranteed due to a manufacturing error.
Retiro De Equipo (Recall) de RADREX-I
  • Tipo de evento
    Recall
  • ID del evento
    57547
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-12-21
  • 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
    In an occurrence it has been found that when an operator performed an exam with the wireless x-ray detector an error message dialog was displayed on the console. after a system reboot the image data was lost.
Retiro De Equipo (Recall) de MICRO-TEMP II LOCALIZED HEAT THERAPY SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    57557
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-09-10
  • 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
    Water leaks from the micro-temp lt model 749. water leaks are due to cracking of the reservoir's heater plate.
Retiro De Equipo (Recall) de CIRCON CABOT FALOPE-RING BAND TUBAL OCCLUSION SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    57831
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-10-02
  • 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
    Due to an anomaly in the packaging process it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. the breach may or may not be easily seen.
Retiro De Equipo (Recall) de DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A1C (HB1C) ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    57846
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-08-17
  • 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
    There has been a change to the acceptable range for the 'e' calibration coefficient guideline. the new guideline range is 5 to 8 (conventional units). the guideline range for lots prior to ga3099 is 6 to 9. the e coefficient range is a criterion used by customers to assess the validity of their calibration. siemens has also noted that some users are not updating scaler values when setting up a calibration (this was implemented beginning with lot ga3009) resulting in inaccurate values for both patients and controls.
Retiro De Equipo (Recall) de 3M SURGICAL CLIPPER PROFESSIONAL
  • Tipo de evento
    Recall
  • ID del evento
    57849
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2018-02-15
  • 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
    3m is notifying all users of the 3m surgical clipper professional 9681 of an added product warning stressing the importance of following proper clipper charging practices as documented in the model 9681 clipper instructions for use.
Retiro De Equipo (Recall) de RAPIDLAB 1265 SYSTEM - ANALYZER
  • Tipo de evento
    Recall
  • ID del evento
    57852
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2006-04-10
  • 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
    Rapidlab 1265 systems may report invalid co-oximeter values to an lis rapidlink or rapidcomm system.
Retiro De Equipo (Recall) de AFFIRMAGEN 3 REAGENT RED BLOOD CELLS (POOLED CELLS)
  • Tipo de evento
    Recall
  • ID del evento
    57862
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-11-04
  • 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
    Ortho clinical diagnostics (ortho) has initiated this recall because ortho has received an increase in customer complaints and has confirmed the intermittent presence of marked hemolysis in ortho reagent red blood cell (rrbc) products as well as quality control products containing red blood cells. ortho conducted an extensive investigation and the root cause for the marked hemolysis has been identified as microbial contamination.
Retiro De Equipo (Recall) de CONFIDENCE PLUS KIT
  • Tipo de evento
    Recall
  • ID del evento
    57872
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-01-15
  • 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
    Depuy spine is recalling all lots of confidence kit spinal cement system and confidence plus kit spinal cement system following reports that the cement mixer used to prepare cement for surgery may not turn properly. the event may be described as the mixer being jammed or stuck.
Retiro De Equipo (Recall) de S5 HEART LUNG MACHINE - MAST MOUNTED ROLLER PUMPS
  • Tipo de evento
    Recall
  • ID del evento
    57885
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-09-20
  • 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
  • Causa
    The manufacturer recently received reports of a 'fault in motor controller' alarm message. if this occurs the pump stops and audible alarm sounds and a visual alarm is displayed. the 'fault in motor controller' message is displayed on the system panel. on some occasions the circuit breaker of the pump on the emergency power pack may also trip.
Retiro De Equipo (Recall) de 2200 INTRAORAL X-RAY SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    57886
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-02-18
  • 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
    A potential problem which could result in an early failure of the scissor arm to bracket connection. the failure can be identified by observing the physical condition of the scissor arm bracket. the plastic covers around the bracket typically show signs of fatigue before the bracket actually breaks. this can be an early indicator of a potential problem.
Retiro De Equipo (Recall) de TONOWASH
  • Tipo de evento
    Recall
  • ID del evento
    59311
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-07-19
  • 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
    It was determined that tonowash devices were being sold to users in canada and that these devices are unlicensed.
Retiro De Equipo (Recall) de VITROS ECI IMMUNODIAGNOSTIC PRODUCTS TOTAL T4 REAGENT PACK
  • Tipo de evento
    Recall
  • ID del evento
    57887
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-06-07
  • 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 (ortho) has initiated this recall because it was determined that the open pack (in use) storage limits must be reduced from 8 weeks to 4 weeks for vitros immunodiagnostic products total t4 (tt4) reagent packs. this change affects expired current (in date) and future product lots.
Retiro De Equipo (Recall) de RAPIDPOINT 500 SYSTEM - LACTATE MEASUREMENT CARTRIDGES
  • Tipo de evento
    Recall
  • ID del evento
    57900
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-05-30
  • 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
    Siemens healthcare diagnostics has received several reports from customers of one or more electrolyte parameters (e.G. na+ ca++ k+ cl-) reporting a "-----?" error code when aqc qc or cvm is run on the rapidpoint 500 blood gas analyzer. when exhibited the tissue is usually seen during level 1 qc/aqc level 1 cvm and sometimes level 2 cvm testing. this issue has also been observed on a small number of patient samples. this issue impacts only rapidpoint 500 measurement cartridges p/ns 10491447 10491448 10491449 and 10844813. siemens has observed this issue with rapidpoint 500 measurement cartridges with serial numbers up to 2412705915 however not all these cartridges will exhibit this behavior. the issue does not impact rapidpoint 400 or rapidpoint 405 measurement cartridges.
Retiro De Equipo (Recall) de EFILM WORKSTATION
  • Tipo de evento
    Recall
  • ID del evento
    57906
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-12-01
  • 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
    This issue happens for rf projection images [the 12 dicom sop classes]. if user measures on rf image "cal" (calibration) is not displayed and measurement is not correct. the "cal" label is not displayed on the projection images after calibration is performed which should be present if the measurement is presented based on pixel spacing.
Retiro De Equipo (Recall) de 3D VIRTUOSO CT POSTPROCESSING WORKSTATION
  • Tipo de evento
    Recall
  • ID del evento
    57914
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2000-11-03
  • 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
    Advisory and software upgrade to correct problem with images.
Retiro De Equipo (Recall) de BD PHOENIX UPDATE DISK
  • Tipo de evento
    Recall
  • ID del evento
    57958
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-04-11
  • 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
  • Causa
    False susceptible vancomycin ast results for emerging strains vancomycin resistant e. faecium (vre).
Retiro De Equipo (Recall) de AUTOSTAINER
  • Tipo de evento
    Recall
  • ID del evento
    57966
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2010-09-30
  • 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
    The autostainers were not licensed devices.
Retiro De Equipo (Recall) de LIFEPAK 15 MONITOR/DEFIBRILLATOR
  • Tipo de evento
    Recall
  • ID del evento
    57989
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-09-08
  • 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
    Physio-control inc. lifepak 15 monitor/defibrillators with etco2 capability are distributed with the etco2 setting preset to display in mmhg. customers may choose to reconfigure the device to display the etco2 in alternative modes of kpa or % settings. when using etco2 in the kpa or % setting and in a situation where the reading is above 9.9 kpa the display of the lifepak 15 respiratory rate may partially obscure a portion of the leading digit of the etco2 value. although part of the first digit of the etco2 value is obscured by the respiratory rate the capnography waveform scale automatically adapts to the etco2 value. observing the capnography waveform and the range displayed will help the user confirm the patient's etco2 value. clinical interpretation of a low etco2 value when the value is actually high could potentially lead to incorrect treatment. there have been no reports of incorrect patient treatment or harm associated with this issue.
Retiro De Equipo (Recall) de SSP UNITRAY - LOW RESOLUTION CLASS I
  • Tipo de evento
    Recall
  • ID del evento
    58090
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-01-18
  • 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
    The taq polymerase is not amplifying dna as intended. there is suspected contamination that is causing the taq to not work properly. kits which contain the affected lot of taq (taq polymerase vial lot # 864459) are not useable unless a different lot of taq is used.
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