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  • Dispositivo 18
  • Fabricante 16
  • Evento 124969
  • Implante 16
Retiro De Equipo (Recall) de Device Recall Minipuncture PeelAway Introducer set
  • Tipo de evento
    Recall
  • ID del evento
    46151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0895-2008
  • Fecha de inicio del evento
    2007-12-07
  • Fecha de publicación del evento
    2008-04-16
  • 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=67054
  • 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
    Catheter Introducer - Product Code DYB
  • Causa
    Packaging problem: the peel-away sheath does not peel uniformly or completely.
  • Acción
    Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.
Retiro De Equipo (Recall) de Device Recall PeelAway Introducer Set
  • Tipo de evento
    Recall
  • ID del evento
    46151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0896-2008
  • Fecha de inicio del evento
    2007-12-07
  • Fecha de publicación del evento
    2008-04-16
  • 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=67056
  • 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
    Catheter Introducer - Product Code DYB
  • Causa
    Packaging problem: the peel-away sheath does not peel uniformly or completely.
  • Acción
    Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.
Retiro De Equipo (Recall) de Device Recall PeelAway Introducer set
  • Tipo de evento
    Recall
  • ID del evento
    46151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0897-2008
  • Fecha de inicio del evento
    2007-12-07
  • Fecha de publicación del evento
    2008-04-16
  • 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=67057
  • 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
    Catheter Introducer - Product Code DYB
  • Causa
    Packaging problem: the peel-away sheath does not peel uniformly or completely.
  • Acción
    Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.
Retiro De Equipo (Recall) de Device Recall PeelAway Introducer set
  • Tipo de evento
    Recall
  • ID del evento
    46151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0898-2008
  • Fecha de inicio del evento
    2007-12-07
  • Fecha de publicación del evento
    2008-04-16
  • 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=67059
  • 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
    Catheter Introducer - Product Code DYB
  • Causa
    Packaging problem: the peel-away sheath does not peel uniformly or completely.
  • Acción
    Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.
Retiro De Equipo (Recall) de Device Recall Stryker Medical Epic II Critical Care Bed with Zoom D...
  • Tipo de evento
    Recall
  • ID del evento
    45908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1688-2008
  • Fecha de inicio del evento
    2008-02-01
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67101
  • 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
    hospital bed - Product Code FNL
  • Causa
    The brakes may not have adequate holding power to lock the bed in place.
  • Acción
    Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.
Retiro De Equipo (Recall) de Device Recall PeelAway Introducer Set Without Wire Guide
  • Tipo de evento
    Recall
  • ID del evento
    46151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0899-2008
  • Fecha de inicio del evento
    2007-12-07
  • Fecha de publicación del evento
    2008-04-16
  • 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=67060
  • 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
    Catheter Introducer - Product Code DYB
  • Causa
    Packaging problem: the peel-away sheath does not peel uniformly or completely.
  • Acción
    Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.
Retiro De Equipo (Recall) de Device Recall PeelAway Introducer Set Without Wire Guide
  • Tipo de evento
    Recall
  • ID del evento
    46151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0900-2008
  • Fecha de inicio del evento
    2007-12-07
  • Fecha de publicación del evento
    2008-04-16
  • 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=67061
  • 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
    Catheter Introducer - Product Code DYB
  • Causa
    Packaging problem: the peel-away sheath does not peel uniformly or completely.
  • Acción
    Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.
Retiro De Equipo (Recall) de Device Recall Cook TPN Double Lumen Catheter Set
  • Tipo de evento
    Recall
  • ID del evento
    46151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0901-2008
  • Fecha de inicio del evento
    2007-12-07
  • Fecha de publicación del evento
    2008-04-16
  • 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=67062
  • 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
    Catheter Introducer - Product Code DYB
  • Causa
    Packaging problem: the peel-away sheath does not peel uniformly or completely.
  • Acción
    Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.
Retiro De Equipo (Recall) de Device Recall Cook TPN Single Lumen Catheter Set
  • Tipo de evento
    Recall
  • ID del evento
    46151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0902-2008
  • Fecha de inicio del evento
    2007-12-07
  • Fecha de publicación del evento
    2008-04-16
  • 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=67064
  • 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
    Catheter Introducer - Product Code DYB
  • Causa
    Packaging problem: the peel-away sheath does not peel uniformly or completely.
  • Acción
    Cook Inc. initially notified consignees via FEDEX by an Urgent: Product Recall on 12/7/07. The recall was then expanded and consignees were notified on 12/18/08 by another Urgent: Product Recall. The letters instructed any distributors to inform their customers of recall, and all users to return the recalled products and enclosed Recall Response Form to the firm. For additional information, contact 1-800-346-2686.
Retiro De Equipo (Recall) de Device Recall Kodak DirectView DR 3000 System
  • Tipo de evento
    Recall
  • ID del evento
    46266
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0731-2008
  • Fecha de inicio del evento
    2007-12-21
  • Fecha de publicación del evento
    2008-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-04-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67065
  • 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
    Stationary X-Ray System - Product Code KPR
  • Causa
    Unintended positioner movement - the u-arm positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after a collision has occurred with the quantum table.
  • Acción
    On 12/21/07, Service Bulletins (dated December 2007) were sent to consignees informing them of design modification, and providing modification instructions. The firm followed up with telephone calls to the direct user sites to schedule appointments to visit each site, in order to make the necessary modifications. The firm will be installing Safety Adaptation Board and software into all the affected DR3000 systems.
Retiro De Equipo (Recall) de Device Recall Stryker Medical Epic II Critical Care Bed; Model 2030.
  • Tipo de evento
    Recall
  • ID del evento
    45908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1686-2008
  • Fecha de inicio del evento
    2008-02-01
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67066
  • 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
    hospital bed - Product Code FNL
  • Causa
    The brakes may not have adequate holding power to lock the bed in place.
  • Acción
    Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.
Retiro De Equipo (Recall) de Device Recall Stryker Medical Epic II Critical Care Bed with Zoom D...
  • Tipo de evento
    Recall
  • ID del evento
    45908
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1687-2008
  • Fecha de inicio del evento
    2008-02-01
  • Fecha de publicación del evento
    2008-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67067
  • 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
    hospital bed - Product Code FNL
  • Causa
    The brakes may not have adequate holding power to lock the bed in place.
  • Acción
    Consignees were notified via letter dated 2/1/08 and informed that upgrade kits along with full written and video installation instructions will be sent to correct the problem.
Retiro De Equipo (Recall) de Device Recall RenalPure
  • Tipo de evento
    Recall
  • ID del evento
    46267
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0871-2008
  • Fecha de inicio del evento
    2007-12-03
  • Fecha de publicación del evento
    2008-02-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67085
  • 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
    Liquid Acid Concentrate. - Product Code KPO
  • Causa
    Foil seal deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and dri-sate product containers older than two years old.
  • Acción
    Firm began notification of consignees by letter, Alert: Voluntary Recall, on 12/03/07, sent via e-mail, fax, and/or mail. Consignees asked to check inventory and to identify and call for the replacement of any product older than 2 years old.
Retiro De Equipo (Recall) de Device Recall RenalPure
  • Tipo de evento
    Recall
  • ID del evento
    46267
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0872-2008
  • Fecha de inicio del evento
    2007-12-03
  • Fecha de publicación del evento
    2008-02-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67086
  • 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
    Liquid Acid Concentrate - Product Code KPO
  • Causa
    Foil seal deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and dri-sate product containers older than two years old.
  • Acción
    Firm began notification of consignees by letter, Alert: Voluntary Recall, on 12/03/07, sent via e-mail, fax, and/or mail. Consignees asked to check inventory and to identify and call for the replacement of any product older than 2 years old.
Retiro De Equipo (Recall) de Device Recall RenalPure
  • Tipo de evento
    Recall
  • ID del evento
    46267
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0873-2008
  • Fecha de inicio del evento
    2007-12-03
  • Fecha de publicación del evento
    2008-02-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67087
  • 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
    Liquid Acid Concentrate - Product Code KPO
  • Causa
    Foil seal deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and dri-sate product containers older than two years old.
  • Acción
    Firm began notification of consignees by letter, Alert: Voluntary Recall, on 12/03/07, sent via e-mail, fax, and/or mail. Consignees asked to check inventory and to identify and call for the replacement of any product older than 2 years old.
Retiro De Equipo (Recall) de Device Recall DriSate Dry
  • Tipo de evento
    Recall
  • ID del evento
    46267
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0874-2008
  • Fecha de inicio del evento
    2007-12-03
  • Fecha de publicación del evento
    2008-02-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67093
  • 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
    Liquid Acid Concentrate - Product Code KPO
  • Causa
    Foil seal deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and dri-sate product containers older than two years old.
  • Acción
    Firm began notification of consignees by letter, Alert: Voluntary Recall, on 12/03/07, sent via e-mail, fax, and/or mail. Consignees asked to check inventory and to identify and call for the replacement of any product older than 2 years old.
Retiro De Equipo (Recall) de Device Recall DriSate
  • Tipo de evento
    Recall
  • ID del evento
    46267
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0875-2008
  • Fecha de inicio del evento
    2007-12-03
  • Fecha de publicación del evento
    2008-02-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67094
  • 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
    Liquid Acid Concentrate. - Product Code KPO
  • Causa
    Foil seal deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and dri-sate product containers older than two years old.
  • Acción
    Firm began notification of consignees by letter, Alert: Voluntary Recall, on 12/03/07, sent via e-mail, fax, and/or mail. Consignees asked to check inventory and to identify and call for the replacement of any product older than 2 years old.
Retiro De Equipo (Recall) de Device Recall GMRS Proximal Femoral Surgical Protocol
  • Tipo de evento
    Recall
  • ID del evento
    46275
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0668-2008
  • Fecha de inicio del evento
    2007-12-18
  • Fecha de publicación del evento
    2008-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67097
  • 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
    Femur Prosthesis Surgical Literature - Product Code JDI
  • Causa
    The gmrs proximal femoral surgical protocol states " the gmrs proximal femoral components are fully compatabile with all stryker v40 femoral heads." this statement is incorrect and conflicts with the alumina head label and packaging insert.
  • Acción
    Stryker sent Urgent Product Recall notification letters and Product Accountability forms via FedEx on 12/21/2007, return receipt requested. An Urgent Product Recall letter dated 1/7/2008, was sent to surgeons who are GMRS users, advising that the GMRS Proximal femoral components are not compatible with Alumina ceramic heads.
Retiro De Equipo (Recall) de Device Recall Horizon Cardiology Hemo Monitoring System
  • Tipo de evento
    Recall
  • ID del evento
    46276
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0710-2008
  • Fecha de inicio del evento
    2007-11-12
  • Fecha de publicación del evento
    2008-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67098
  • 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
    Programmable Diagnostic Computer - Product Code DQK
  • Causa
    Power supply reliability: mckesson received word from their manufacturer of the medical grade power supply that some power grade supplies may not provide reliable power output.
  • Acción
    Recalled by letter sent to the firm's customers beginning on 11-12-2007, advising them that the field correction would be completed by the recalling firm service technicians.
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