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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Retiro De Equipo (Recall) de Device Recall TransportAir
  • Tipo de evento
    Recall
  • ID del evento
    25201
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0718-03
  • Fecha de inicio del evento
    1997-06-01
  • Fecha de publicación del evento
    2003-04-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-07-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25372
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Bed, Air Fluidized - Product Code INX
  • Causa
    Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.
  • Acción
    In approximately November 1997 the firm implemented the TransportAir retrograde for all active units.
Retiro De Equipo (Recall) de BariAir
  • Tipo de evento
    Recall
  • ID del evento
    25197
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0414-03
  • Fecha de inicio del evento
    1998-10-21
  • Fecha de publicación del evento
    2003-01-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-01-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25366
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Bed, Ac-Powered Adjustable Hospital - Product Code FNL
  • Causa
    Electrical failure of the bed due to fluid egress into the junction box.
  • Acción
    In an October 21, 1998 e-mail the firm requested return of the product for a planned upgrade. The junction box cover was corrected at the same time of the upgrade.
Retiro De Equipo (Recall) de Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent ...
  • Tipo de evento
    Recall
  • ID del evento
    26562
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1065-03
  • Fecha de inicio del evento
    2000-02-24
  • Fecha de publicación del evento
    2003-07-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27897
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme Linked Immunoabsorbent Assay, Rubella - Product Code LFX
  • Causa
    The high positive control/low positive standard ratio recovering too low.
  • Acción
    Recall letters sent out via DHL on 2/24/2000
Retiro De Equipo (Recall) de iLab Ultrasound Imaging System
  • Tipo de evento
    Recall
  • ID del evento
    47759
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1693-2008
  • Fecha de inicio del evento
    2000-04-11
  • Fecha de publicación del evento
    2008-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-04-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70087
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ultrasound imaging system - Product Code IYO
  • Causa
    Improperly terminated wires on a component of the ilab acquisition processor power supply could cause the processor to lock-up or stop, and prolong the patients procedure.
  • Acción
    On April 4 and 10, 2008, customer notifcations were sent to consignees. Field corrections are estimated to begin on April 25, 2008.
Retiro De Equipo (Recall) de Kinetic Concepts
  • Tipo de evento
    Recall
  • ID del evento
    25452
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0752-03
  • Fecha de inicio del evento
    2000-04-11
  • Fecha de publicación del evento
    2003-04-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25857
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Bed, Flotation Therapy, Powered - Product Code IOQ
  • Causa
    Battery failure/ outgassing.
  • Acción
    Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
Retiro De Equipo (Recall) de Kinetic Concepts
  • Tipo de evento
    Recall
  • ID del evento
    25452
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0751-03
  • Fecha de inicio del evento
    2000-04-11
  • Fecha de publicación del evento
    2003-04-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25856
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Bed, Flotation Therapy, Powered - Product Code IOQ
  • Causa
    Battery failure/ outgassing.
  • Acción
    Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
Retiro De Equipo (Recall) de Kinetic Concepts
  • Tipo de evento
    Recall
  • ID del evento
    25452
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0750-03
  • Fecha de inicio del evento
    2000-04-11
  • Fecha de publicación del evento
    2003-04-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25855
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Bed, Flotation Therapy, Powered - Product Code IOQ
  • Causa
    Battery failure/ outgassing.
  • Acción
    Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
Retiro De Equipo (Recall) de Kinetic Concepts
  • Tipo de evento
    Recall
  • ID del evento
    25452
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0749-03
  • Fecha de inicio del evento
    2000-04-11
  • Fecha de publicación del evento
    2003-04-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25854
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Bed, Flotation Therapy, Powered - Product Code IOQ
  • Causa
    Battery failure/ outgassing.
  • Acción
    Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
Retiro De Equipo (Recall) de Kinetic Concepts
  • Tipo de evento
    Recall
  • ID del evento
    25452
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0748-03
  • Fecha de inicio del evento
    2000-04-11
  • Fecha de publicación del evento
    2003-04-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25853
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Bed, Flotation Therapy, Powered - Product Code IOQ
  • Causa
    Battery failure/ outgassing.
  • Acción
    Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.
Retiro De Equipo (Recall) de DURACUF
  • Tipo de evento
    Recall
  • ID del evento
    26245
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1236-03
  • Fecha de inicio del evento
    2000-10-24
  • Fecha de publicación del evento
    2003-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27368
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    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 data.
  • Notas adicionales en la data
  • Causa
    Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
  • Acción
    A Recall notification letter was mailed to all direct accounts on 10/24/2000 followed by a telephone call to each direct account. Distributors were not requested to subrecall because Critikon already knew the hospital accounts that had recieved product and they were notified via the 10/24/00 letter and phone call. Accounts were told to return product to Critikon for replacement.
Retiro De Equipo (Recall) de Device Recall Critikon
  • Tipo de evento
    Recall
  • ID del evento
    26278
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0015-04
  • Fecha de inicio del evento
    2000-11-16
  • Fecha de publicación del evento
    2003-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27424
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
  • Causa
    Instructions for use contained incorrect sensor reference.
  • Acción
    A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.
Retiro De Equipo (Recall) de Device Recall Critikon
  • Tipo de evento
    Recall
  • ID del evento
    26278
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0014-04
  • Fecha de inicio del evento
    2000-11-16
  • Fecha de publicación del evento
    2003-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27423
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
  • Causa
    Instructions for use contained incorrect sensor reference.
  • Acción
    A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.
Retiro De Equipo (Recall) de Device Recall Critikon
  • Tipo de evento
    Recall
  • ID del evento
    26278
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0013-04
  • Fecha de inicio del evento
    2000-11-16
  • Fecha de publicación del evento
    2003-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27422
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    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 data.
  • Notas adicionales en la data
  • Causa
    Instructions for use contained incorrect sensor reference.
  • Acción
    A recall notification letter with the correct 'Instructions for Use' attached, was mailed certified return receipt requested to accounts on 11/16/2000. Follow-up contact was made by mail or telephone until 100% response was completed. No return of product was requested but rather users were provided with the correct instructions for use.
Retiro De Equipo (Recall) de Device Recall AEROSET
  • Tipo de evento
    Recall
  • ID del evento
    26640
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1142-03
  • Fecha de inicio del evento
    2000-12-29
  • Fecha de publicación del evento
    2003-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-08-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28044
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Causa
    Ict assays run using a manual dilution will not be calculated correctly by the software.
  • Acción
    Product Information letter dated 29 December 2000 was sent to all AEROSET customers.
Retiro De Equipo (Recall) de Device Recall SoftPath
  • Tipo de evento
    Recall
  • ID del evento
    35375
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1252-06
  • Fecha de inicio del evento
    2001-01-09
  • Fecha de publicación del evento
    2006-07-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45949
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    pathology lab software - Product Code JQP
  • Causa
    The client had made a decision to use the softpath module in a nonstandard manner. under specific circumstances, incorrect text may appear on a patient report.
  • Acción
    The firm issued a software correction letter to its consignees 1/9/2001, advising them of the problem and supplied them with a software patch ICC number 3618 also referred to as release 3.0. The firm advised its clients that the installation of this software to their system was mandatory.
Retiro De Equipo (Recall) de Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet...
  • Tipo de evento
    Recall
  • ID del evento
    30641
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0340-05
  • Fecha de inicio del evento
    2001-01-25
  • Fecha de publicación del evento
    2004-12-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-12-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36256
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Cord, Electric, For Endoscope - Product Code FFZ
  • Causa
    An incorrect electrosurgical cord was included in some of the packages.
  • Acción
    Consignees were notified by letter sent Federal Express on 01/25/2001.
Retiro De Equipo (Recall) de Device Recall PROTOCOL Blood Pressure Cuff
  • Tipo de evento
    Recall
  • ID del evento
    26287
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1237-03
  • Fecha de inicio del evento
    2001-03-07
  • Fecha de publicación del evento
    2003-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27436
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
  • Causa
    Wrong connector attached to blood pressure cuff.
  • Acción
    The recalling firm telephoned the one account involved on 3/7/2001 and also mailed a Recall Notification letter to the firm on 3/7/2001 requesting return of the product.
Retiro De Equipo (Recall) de Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked imm...
  • Tipo de evento
    Recall
  • ID del evento
    26402
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0961-03
  • Fecha de inicio del evento
    2001-03-19
  • Fecha de publicación del evento
    2003-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-10-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27616
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Enzyme Linked Immunoabsorbent Assay, Rubeola Igg - Product Code LJB
  • Causa
    Mix-up between low positive and negative controls.
  • Acción
    Recall letter was sent via DHL to Biotest on 3/19/2001. Product was to be returned to Zeus.
Retiro De Equipo (Recall) de Device Recall ProLong
  • Tipo de evento
    Recall
  • ID del evento
    26498
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1003-03
  • Fecha de inicio del evento
    2001-05-09
  • Fecha de publicación del evento
    2003-07-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-07-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27779
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Anesthesia Conduction Kit - Product Code CAZ
  • Causa
    Catheter does not fit through the needle resulting in delay of medical procedure.
  • Acción
    The firm initiated the recall via letter to all consignees on May 9, 2001.
Retiro De Equipo (Recall) de Device Recall Espirit Ventilator
  • Tipo de evento
    Recall
  • ID del evento
    28803
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0903-04
  • Fecha de inicio del evento
    2001-06-01
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-05-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32535
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Causa
    Ventilator would spontaneously suspend ventilatory support to patients due to a hardware/software compatibility issue.
  • Acción
    Firm technicians and foreign representatives were responsible for updating software on or about 6/1/01.
Retiro De Equipo (Recall) de ESPRIT VENTILATOR, Model V1000
  • Tipo de evento
    Recall
  • ID del evento
    26432
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0951-03
  • Fecha de inicio del evento
    2001-06-08
  • Fecha de publicación del evento
    2003-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27672
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    unknown device name - Product Code CPK
  • Causa
    Material hardness on original design check valve may cause premature failure.
  • Acción
    Firm plans to replace all of the check valves in the field. Recall was communicated by issuance of a Field Communication 2001-25 dated 8 June 2001.
Retiro De Equipo (Recall) de Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeu...
  • Tipo de evento
    Recall
  • ID del evento
    26578
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1147-03
  • Fecha de inicio del evento
    2001-06-22
  • Fecha de publicación del evento
    2003-08-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-08-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27930
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, Test, Anticardiolipin Immunological - Product Code MID
  • Causa
    Bacterial contamination of the high positive control.
  • Acción
    Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.
Retiro De Equipo (Recall) de Device Recall Asahi APS Series Dialyzers
  • Tipo de evento
    Recall
  • ID del evento
    28341
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0739-04
  • Fecha de inicio del evento
    2001-10-01
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-03-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31622
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
  • Causa
    Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis.
  • Acción
    Asahi visited each of the U.S. customers starting on 10/1/01, observing how the facility handles the dialyzer before pre-cleaning, during pre-cleaning and priming. The users were retrained in the reprocessing steps, emphasizing the controls and care to be taken during pre-cleaning, including the verification of water pressure.
Retiro De Equipo (Recall) de Device Recall AEROSET
  • Tipo de evento
    Recall
  • ID del evento
    25770
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0843-03
  • Fecha de inicio del evento
    2001-10-02
  • Fecha de publicación del evento
    2003-05-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-04-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26456
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Causa
    Extensive use of cuvettes causes inaccurate results. preventative maintenance did not specify replacement schedule.
  • Acción
    The firm issued a letter to affected consignees on or about 10/02/2001 notifying the consignees that an Abbott Field Representative will perform a one-time cuvette upgrade to the consignee''s AEROSET system.
Retiro De Equipo (Recall) de Prowler Plus
  • Tipo de evento
    Recall
  • ID del evento
    26334
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0018-04
  • Fecha de inicio del evento
    2001-10-19
  • Fecha de publicación del evento
    2003-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27526
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    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 data.
  • Notas adicionales en la data
  • Causa
    These catheters have j-shape tips instead of the labeled mp (multipurpose) tips and also are packed into the incorrect tip tray.
  • Acción
    The firm initiated a recall of the product shipped to Japan via an e-mail notification on 8/20/2001 requesting return of the devices. The firm mailed recall notification letters to accounts in the United States on 10/19/2001. The firm considers the recall complete and effective and has accounted for all devices involved.
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