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  • Dispositivo 1
  • Fabricante 1
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de DIGITAL FLUOROGRAPHY SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    61102
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-11-10
  • 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
    Toshiba has issued a field modification instruction to update the software to preserve the images acquired.
Retiro De Equipo (Recall) de UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    61135
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-05-02
  • 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
    Beckman coulter has confirmed an issue where the red blood cell (rbc) aperture baths can contain residue in the sweep flow fittings. this residue may potentially create increased background failures flagged results and vote outs for rbc and platelet (plt) parameters.
Retiro De Equipo (Recall) de UNICEL DXC 600I SYNCHRON ACCESS CLINICAL ANALYZER
  • Tipo de evento
    Recall
  • ID del evento
    61214
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-02-12
  • 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 newly released aluminum incubator belt pulley is defective and may rub against the light shield which causes the formation of debris. this debris can fall into the reaction vessels and present a risk of erroneous test results.
Retiro De Equipo (Recall) de ABL700
  • Tipo de evento
    Recall
  • ID del evento
    61257
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2006-08-08
  • 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
    Calibration solution for abl700 blood gas analysers is labeled with an incorrect bar code. the bar code identified on the cal solution 2 product is actually the bar code for the rinse solution.
Retiro De Equipo (Recall) de AW VOLUMESHARE 5 - CT APPLICATIONS
  • Tipo de evento
    Recall
  • ID del evento
    61282
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-09-16
  • 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
    The gsi viewer application running on aw/volume share or on the aw server when making a batch and rotating the batch group clockwise 180 degrees (inferior to superior) will display images in the superior orientation. the orientation annotation on the image is correct.
Retiro De Equipo (Recall) de ARCHITECT "I" SYSTEM - STAT TROPONIN-I ASSAY
  • Tipo de evento
    Recall
  • ID del evento
    61292
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2007-03-16
  • 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
    Analytical sensitivity label claim of less than or equal to 0.01 ng/ml (ug/l) might not be met for all lots of architect stat troponin-i reagents.
Retiro De Equipo (Recall) de VITROS CHEMISTRY PRODUCTS SYSTEM - UPRO SLIDES (URINE PROTEIN)
  • Tipo de evento
    Recall
  • ID del evento
    61295
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2008-10-23
  • 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
    Some boxes of vitros chemistry products calibrator kit 10 lot 0198 that were shipped between august 8 2008 and october 16 2008 were stored improperly before shipment to canada.
Retiro De Equipo (Recall) de VERTIER SURGICAL TABLE
  • Tipo de evento
    Recall
  • ID del evento
    61296
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-11-11
  • 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
    The table may experience involuntary movement as a result of fluid intrusion. this hazard can arise especially when the table is in the trendelenburg or anti-trendelenburg position allowing fluids such as saline or water to enter the table column.
Retiro De Equipo (Recall) de AXIOM SENSIS SYSTEM - HEMODYNAMIC APPLICATON
  • Tipo de evento
    Recall
  • ID del evento
    61309
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2004-07-20
  • 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
    Axiom artis advisory letter - possible error in the calculation of value area.
Retiro De Equipo (Recall) de LIT HOPITAL (ELECTRIQUE) BERTEC
  • Tipo de evento
    Recall
  • ID del evento
    61311
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-06-26
  • 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
    Siderails do not always stay locked while in the up position. mainly du to unscrewing bolts that are holding the siderail mechanism.
Retiro De Equipo (Recall) de SUPPORT DE RIDELLES SECURIS POUR LITS EURO
  • Tipo de evento
    Recall
  • ID del evento
    61312
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-05-02
  • 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
    Le cliquets maintenant la demi-ridelle en position haute peut parfois s'il n'est pas assez long se desenclencher dans certaines situation. dans ce cas la demi-ridelle va coulisser pour se retrouver en position basse et cela peut ainsi faire perdre l'equilibre au patient qui prend appui sur la demi-ridelle entrainant un risque de chute et donc de blessure.
Retiro De Equipo (Recall) de MEDRAD INTEGO PET INFUSION SYSTEM - MAIN
  • Tipo de evento
    Recall
  • ID del evento
    61319
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-05-27
  • 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
    In january 2016 a customer complaint reported a mismatch between the prescribed dose value displayed on the screen and the prescribed dose value printed by the printer. the dose activity infused was as intended and printed correctly.
Retiro De Equipo (Recall) de HITACHI LDL-CHOLESTEROL NO PRETREATMENT LDL-C PLUS 2ND GEN.
  • Tipo de evento
    Recall
  • ID del evento
    61332
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-10-11
  • 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
    Internal investigation revealed the instability of an enzyme in r1 which is used to suppress the ascorbic acid interference.
Retiro De Equipo (Recall) de ALLSET GOLD ABC LOW RESOLUTION KIT
  • Tipo de evento
    Recall
  • ID del evento
    61343
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-03-12
  • 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
    When using 54340d allset+ gold hla abc low res kit lot 038 1249868 primer mix pm085c has been shown to produce a weak false positive reaction of correct size (420 base pair pcr amplicon) in the presence of samples containing c*04 homozygote allele(s). primer mix pm085c can be found in lane 78. as a result of the false positive reaction samples containing two c*04 alleles could produce a mistype or no-type result depending on the reaction pattern corresponding to the full abc hla typing.
Retiro De Equipo (Recall) de PINNACLE 3 PRO 3DTPS WITH SB2000 DICOM RT UPGRADE
  • Tipo de evento
    Recall
  • ID del evento
    61356
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2003-07-16
  • 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
    Incorrect dose delivery to the patient may occur.
Retiro De Equipo (Recall) de VECTOR TEMPORARY ANCHORAGE SYSTEM - MINI SCREWS
  • Tipo de evento
    Recall
  • ID del evento
    61358
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-07-18
  • 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
    Some screws in the affected lot were machined undersized at the top of the threads which potentially caused weakening of the screw.
Retiro De Equipo (Recall) de SYNCHRON SYSTEMS PREALBUMIN REAGENT
  • Tipo de evento
    Recall
  • ID del evento
    61367
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2003-06-10
  • 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
    The reagent may not be stable until the expiration date printed on the kit. this may result in qc values not recovering within the established ranges.
Retiro De Equipo (Recall) de UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    61369
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-04-05
  • 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
    The nrbc differential or reticulocyte mix chamber drain ports may become plugged by rubber pieces from specimen tube caps and result in biohazard or chemical exposure and/or the potential for generating incorrect results.
Retiro De Equipo (Recall) de SOMATOM BALANCE
  • Tipo de evento
    Recall
  • ID del evento
    61370
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2003-11-11
  • 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
    Evolve hardware and software update va47c (p10 step 1).
Retiro De Equipo (Recall) de DIMENSION EXL SYSTEM - DIMENSION EXL ANALYZER WITH LOCI MODULE
  • Tipo de evento
    Recall
  • ID del evento
    61376
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-03-06
  • 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
    Siemens healthcare diagnostics has confirmed an increase in system check failures due to high system check loci results. many of these errors are due to the current limit set for system check loci results. the errors have no impact on test results but may cause customer inconvenience.
Retiro De Equipo (Recall) de I-STAT KAOLIN ACT CARTRIDGE
  • Tipo de evento
    Recall
  • ID del evento
    61402
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-02-23
  • 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
    Abbott point of care inc. (apoc) has determined that celite act and kaolin act cartridges may produce falsely low results when very high clotting time samples are tested. patient samples with a measured clot time of >853 seconds for celite and >1134 seconds for kaolin may display results of approximately 100 to 200 seconds while using jams142e. the typical therapeutic range of the i-stat act assay is 200 to 600 seconds.
Retiro De Equipo (Recall) de HELIOS 3000 TRACK MOUNT DENTAL LIGHT
  • Tipo de evento
    Recall
  • ID del evento
    61435
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-02-25
  • 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
    The pelton & crane dental lights were erroneaously distributed missing two (2) 8/32x3/16 set screws. the two missing set screws help secure the light from unscrewing and falling off the column during the life of the device. this failure could result in potential injury to either the patient or the end user.
Retiro De Equipo (Recall) de SERACLONE ANTI-S (UPPERCASE) (MNS3)
  • Tipo de evento
    Recall
  • ID del evento
    61437
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-10
  • 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
    The latest internal real-time stability tests for seraclone anti-s have revealed a potential decrease in reactivity of listed lots.
Retiro De Equipo (Recall) de INTERTECH SINGLE USE RESUSCITATOR (ADULT)
  • Tipo de evento
    Recall
  • ID del evento
    61449
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1996-09-07
  • 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
Retiro De Equipo (Recall) de THERMABLATE EAS - TREATMENT CONTROL UNIT (TCU)
  • Tipo de evento
    Recall
  • ID del evento
    62260
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2003-12-12
  • 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
    See comments.
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