• Acerca de la base de datos
  • ¿Cómo usar la IMDD?
  • Descargar la data
  • Preguntas frecuentes
  • Créditos
Vista de la lista Vista de las tarjetas
  • Dispositivo 19
  • Fabricante 5
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de TECHNICON HEMATOLOGY LEUCOCYTE REAGENTS
  • Tipo de evento
    Recall
  • ID del evento
    50420
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1998-01-16
  • 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
    Presence of particulate matter in some bottles may cause high wbc background counts as evidence by increasing noise signals on peroxidase channel of this system causing flag to raise.
Retiro De Equipo (Recall) de VASCUTEK GELSOFT VASCULAR PROSTHESIS-AXILLO FEMORAL
  • Tipo de evento
    Recall
  • ID del evento
    50427
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-12-12
  • 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
    To inform customers about updates to the instructions for use (ifu) for the listed gelatin sealed products. these updates now mandate soaking prostheses/patches in sterile saline solution for 5 minutes prior to implantation and include information on the use of formaldehyde in the manufacturing process.
Retiro De Equipo (Recall) de OLYMPUS EVIS BRONCHOVIDEOSCOPE WITH ACCESSORIES
  • Tipo de evento
    Recall
  • ID del evento
    50432
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2002-01-08
  • 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
Retiro De Equipo (Recall) de H.LEE SAFESHEATH SUBCLAVIAN INTRODUCER SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    50440
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-05-06
  • 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
    Thomas medical products has become aware that in some instances the pouch seal that maintains the sterility of the product may be weak or open and compromise the sterile barrier.
Retiro De Equipo (Recall) de CONNECTION BRACKET FOR MAGNUS OR TABLE SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    50456
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-09-24
  • 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 connection bracket shows too much machanical play at the operating room table interface for some procedures. the cause of this play is that the hole in the lock washer which is responsible for locking the accessory to the operating room table interface is too large.
Retiro De Equipo (Recall) de 23 INSTRUMENT TRAY
  • Tipo de evento
    Recall
  • ID del evento
    50466
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-05-11
  • 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
    Stryker endoscopy has identified a lack of clarity in the insturctions for use (ifu) that had been sent out with trays shipped prior to april 292010.
Retiro De Equipo (Recall) de STERRAD 100 S STERILIZER
  • Tipo de evento
    Recall
  • ID del evento
    50472
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-05-02
  • 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
    The manufacturer received customer reports that their sterrad sterilizers were emitting a mist due to premature mechanical failure of the oil mist filter.There is no impact on requirements to achieve sterility.
Retiro De Equipo (Recall) de ARRAY SYSTEM ASO REAGENT (ANTI-STREPTOLYSIN O REAGENT)
  • Tipo de evento
    Recall
  • ID del evento
    50475
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2004-11-19
  • 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
    The chemstry code that is printed on the bottle is wrong.
Retiro De Equipo (Recall) de BLOOD PACK UNIT WITH CPD
  • Tipo de evento
    Recall
  • ID del evento
    50476
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-02-26
  • 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 leaks along the left tab seal. reports of tab leaks in an alternative product code used the same post filtration red-cell storage bag during manufacturing or transportation.
Retiro De Equipo (Recall) de FRESH IMPRESSION BRAND LATEX GLOVES POWDER-FREE
  • Tipo de evento
    Recall
  • ID del evento
    50517
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2013-11-14
  • 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
    Labelling of d-3vnp products is misleading due to the presence of the word "medical" that may be construed as gloves for medical use.
Retiro De Equipo (Recall) de MERGE PACS
  • Tipo de evento
    Recall
  • ID del evento
    50526
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-07-29
  • 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
    Unviewed images may not display after the last hanging protocol (hp) step when the user preference setting "show unviewed images after the last hanging protocol (mg only)" is selected. this can occur if the last hp step was skipped. this is most commonly encountered if there are additonal views created for the study.
Retiro De Equipo (Recall) de FIBRIN(OGEN) DEGRADATION PRODUCTS
  • Tipo de evento
    Recall
  • ID del evento
    50527
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2003-03-13
  • 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
    The positive controls showed only a weak or no agglutination which could result in false negative results.
Retiro De Equipo (Recall) de DADE LIQUID URINE CONTROL
  • Tipo de evento
    Recall
  • ID del evento
    50549
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    1998-10-02
  • 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
    Inability to recover values within published ranges for several constituents.
Retiro De Equipo (Recall) de SERVER SOFTWARE
  • Tipo de evento
    Recall
  • ID del evento
    50581
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-02-18
  • 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
    If ypu use a ")" as a decimal symbol instead of a "." in the windows regional settingthe values to the right of the decimal comma are truncated for measurements made with the workplace measurement tool.
Retiro De Equipo (Recall) de ROCHE HITACHI - PHENOBARBITAL
  • Tipo de evento
    Recall
  • ID del evento
    50595
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2001-11-28
  • 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
    The reagent buffer bottles has been mislabeled.
Retiro De Equipo (Recall) de SERVO-I VENTILATOR SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    50596
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-01-06
  • 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 risk of electric shock from the ac/dc converter of the affected unit.
Retiro De Equipo (Recall) de DIMENSION VISTA SYSTEM - HCYS FLEX REAGENT
  • Tipo de evento
    Recall
  • ID del evento
    50598
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-05-24
  • 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
    Siemens healthcare diagnostics has confirmed that the dimension vista flex hcys reagent cartridge catalog # k7044 lot number 15243ma shows a reduced open well stability that does not meet the claimed time frame. as a consequence qc recoveries can be found below the assigned ranges giving invalid runs that may prompt customers to a new calibration.
Retiro De Equipo (Recall) de MAXIMOVE PATIENT LIFT
  • Tipo de evento
    Recall
  • ID del evento
    50601
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2008-09-18
  • 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
    Reports indicating the hanger bars have been found to involuntarily dislocate due to contact with riding surfaces such as beds chair armrest or toilet commode chair could result in detachment from the jib.
Retiro De Equipo (Recall) de SUPREME(TM) ELECTROPHYSIOLOGY CATHETER
  • Tipo de evento
    Recall
  • ID del evento
    50611
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2006-06-30
  • 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
    Manufacturer has determined a small number of catheter packaged and labeled as 65 cm length were in fact actually 120 cm in length.
Retiro De Equipo (Recall) de ATRICURE CRYO MODULE SYSTEM - ATRICURE CRYO MODULE
  • Tipo de evento
    Recall
  • ID del evento
    50614
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2012-07-11
  • 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
    Atricure has become aware of complaints regarding the acm1 related to customer satisfaction / user annoyance. specifically a high temperature error (exceeding 40 c) which results in a p2 error. the p2 error is a hard fault which requires the acm unit to be manually reset per the user manual. there is no risk to the patient as a result of the system shutdown.
Retiro De Equipo (Recall) de 24K IRRIGATION SYSTEM - INFLOW/OUTFLOW/SUCTION TUBE SET
  • Tipo de evento
    Recall
  • ID del evento
    50618
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-09-20
  • 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 company has confirmed complaints where the red tint waste tube line is reversed with the clear suction line. product in finished goods inventory has been placed on hold by conmed linvatec and segregated to prevent inadvertent distribution.
Retiro De Equipo (Recall) de VITROS ECI IMMUNODIAGNOSTIC SYSTEM - NTPROBNP REAGENT PACK
  • Tipo de evento
    Recall
  • ID del evento
    50619
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2014-12-29
  • 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
    Ortho clinical diagnostics has changed the limit of detection (lod) and measuring (reportable) range for the vitros ntprobnp reagent packs.
Retiro De Equipo (Recall) de MICROSCAN COMBO PANELS
  • Tipo de evento
    Recall
  • ID del evento
    50623
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    1996-11-26
  • 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
Retiro De Equipo (Recall) de GENESIS II KNEE SYSTEM - POROUS CRUCIATE RETAINING FEMORAL COMPONENTS
  • Tipo de evento
    Recall
  • ID del evento
    50625
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2000-05-30
  • 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
    Beads may dislodged from porous coating due to insufficent temperature for proper bead/substrate adhesion.
Retiro De Equipo (Recall) de PRISMA SET/PRE SET
  • Tipo de evento
    Recall
  • ID del evento
    50628
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2005-12-14
  • 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
    The manufacturer has become aware of several events of access pressure pod leakage when unloading the prisma sets from the prisma system after disconnecting the patient.
  • 1
  • 2
  • 3
  • …
  • Next ›
  • Last »

Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

  • Preguntas frecuentes
  • Acerca de la base de datos
  • Contáctenos
  • Créditos

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

Aviso

Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.

Descargar la data

La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

Descargar todo (zipped)