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  • Dispositivo 26490
  • Fabricante 33665
  • Evento 35826
  • Implante 7175
Retiro De Equipo (Recall) de Device Recall Beckman Coulter
  • Tipo de evento
    Recall
  • ID del evento
    27323
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0046-04
  • Fecha de inicio del evento
    2003-08-26
  • Fecha de publicación del evento
    2003-10-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-04-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29678
  • 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
    Counter, Differential Cell - Product Code GKZ
  • Causa
    Package insert contains inaccurate information.
Retiro De Equipo (Recall) de Device Recall Cronex
  • Tipo de evento
    Recall
  • ID del evento
    34890
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0754-06
  • Fecha de inicio del evento
    2006-02-16
  • Fecha de publicación del evento
    2006-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44893
  • 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
    Medical Screen X-Ray Film - Product Code JAC
  • Causa
    A localized fog pattern appears on the film.
  • Acción
    Consignees were notified by telephone on 02/16/2006.
Retiro De Equipo (Recall) de Device Recall Curix
  • Tipo de evento
    Recall
  • ID del evento
    34890
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0755-06
  • Fecha de inicio del evento
    2006-02-16
  • Fecha de publicación del evento
    2006-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44894
  • 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
    Medical Screen X-Ray Film - Product Code JAC
  • Causa
    A localized fog pattern appears on the film.
  • Acción
    Consignees were notified by telephone on 02/16/2006.
Retiro De Equipo (Recall) de Device Recall Radiomat
  • Tipo de evento
    Recall
  • ID del evento
    34890
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0756-06
  • Fecha de inicio del evento
    2006-02-16
  • Fecha de publicación del evento
    2006-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44895
  • 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
    Medical Screen X-Ray Film - Product Code JAC
  • Causa
    A localized fog pattern appears on the film.
  • Acción
    Consignees were notified by telephone on 02/16/2006.
Retiro De Equipo (Recall) de Device Recall Brilliance 16 Computed Tomography Xray systems
  • Tipo de evento
    Recall
  • ID del evento
    73750
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2369-2016
  • Fecha de inicio del evento
    2016-03-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144870
  • 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, x-ray, tomography, computed - Product Code JAK
  • Causa
    Software defect causing intermittently slow response of host.
  • Acción
    On 3/24/2016 the firm mailed Customer Information letters to their customers.
Retiro De Equipo (Recall) de Device Recall Nuclear, Magnetic Resonance Imaging
  • Tipo de evento
    Recall
  • ID del evento
    79451
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1430-2018
  • Fecha de inicio del evento
    2018-03-16
  • Fecha de publicación del evento
    2018-04-18
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162712
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Potential risk for helium gas inside the mr examination room during a magnet quench.
  • Acción
    On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm. **Action to be Taken by Customer**: During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use: Release of helium gas in the examination room" If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation. If helium enters the examination room: " Immediately remove all persons from the examination room. " Do not switch off air circulation and ventilation in the examination room. " Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level. "Emergency procedures" The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. (Instructions for Use R5.3) Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
Retiro De Equipo (Recall) de Device Recall Precision Blood Glucose Test Strips
  • Tipo de evento
    Recall
  • ID del evento
    25087
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0403-03
  • Fecha de inicio del evento
    2002-11-08
  • Fecha de publicación del evento
    2002-12-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-13
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25134
  • 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
    Glucose Oxidase, Glucose - Product Code CGA
  • Causa
    Use of glucose blood strips may provide false high results.
  • Acción
    Abbott notified the two hospitals by telephone on 11/8/02. Both responded and returned product.
Retiro De Equipo (Recall) de Device Recall Optima
  • Tipo de evento
    Recall
  • ID del evento
    25105
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0348-03
  • Fecha de inicio del evento
    2002-11-26
  • Fecha de publicación del evento
    2002-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-06-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25197
  • 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
    Lenses, Soft Contact, Extended Wear - Product Code LPM
  • Causa
    Lenses labeled as -2.25 diopter contain -0.75 diopter lenses.
  • Acción
    Letters dated 12/2/02 issued to distributors and practitioners requesting return of the affected lot.
Retiro De Equipo (Recall) de iVIEW DAB Detecion Kit. || Catalog Number 760-091
  • Tipo de evento
    Recall
  • ID del evento
    26321
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0928-03
  • Fecha de inicio del evento
    2003-05-07
  • Fecha de publicación del evento
    2003-06-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-05-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27506
  • 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
    Reagent, Immunoassay, Igg - Product Code KTO
  • Causa
    Kit does not stain tissues properly.
  • Acción
    Recall notification was made by telephone on May 6 and 7, 2003. A faxed letter and response form followed.
Retiro De Equipo (Recall) de Device Recall MagNA Pure LC
  • Tipo de evento
    Recall
  • ID del evento
    26366
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1001-03
  • Fecha de inicio del evento
    2003-05-27
  • Fecha de publicación del evento
    2003-07-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27570
  • 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
    Potential for false negative patient results with software version 3.0.
  • Acción
    An Urgent Product Correction letter dated 5/27/03 was sent to each customer.
Retiro De Equipo (Recall) de Device Recall Neonatal Total Galactose Test Kit
  • Tipo de evento
    Recall
  • ID del evento
    26412
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0969-03
  • Fecha de inicio del evento
    2003-05-30
  • Fecha de publicación del evento
    2003-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27639
  • 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
    Enzymatic Methods, Galactose - Product Code JIA
  • Causa
    The device is not stable throughout its labeled expiration date.
  • Acción
    The firm contacted their customers by telephone and facsimile on 5/30/2003.
Retiro De Equipo (Recall) de Device Recall Nuclear, Magnetic Resonance Imaging
  • Tipo de evento
    Recall
  • ID del evento
    79451
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1431-2018
  • Fecha de inicio del evento
    2018-03-16
  • Fecha de publicación del evento
    2018-04-18
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162716
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Potential risk for helium gas inside the mr examination room during a magnet quench.
  • Acción
    On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm. **Action to be Taken by Customer**: During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use: Release of helium gas in the examination room" If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation. If helium enters the examination room: " Immediately remove all persons from the examination room. " Do not switch off air circulation and ventilation in the examination room. " Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level. "Emergency procedures" The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. (Instructions for Use R5.3) Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
Retiro De Equipo (Recall) de Device Recall Neonatal Total Galactose Test Kit
  • Tipo de evento
    Recall
  • ID del evento
    26412
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0970-03
  • Fecha de inicio del evento
    2003-05-30
  • Fecha de publicación del evento
    2003-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27640
  • 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
    Enzymatic Methods, Galactose - Product Code JIA
  • Causa
    The device is not stable throughout its labeled expiration date.
  • Acción
    The firm contacted their customers by telephone and facsimile on 5/30/2003.
Retiro De Equipo (Recall) de IMMAGE IgM Reagent || Part No.: 447610
  • Tipo de evento
    Recall
  • ID del evento
    29094
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1150-04
  • Fecha de inicio del evento
    2003-06-06
  • Fecha de publicación del evento
    2004-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-08-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33127
  • 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
    Igg, Antigen, Antiserum, Control - Product Code DEW
  • Causa
    Low level igm serum sample results may be suppressed and an error code generated when using affected lots. error codes are seen as e60 or e66.
Retiro De Equipo (Recall) de Array Systems Calibrator 5 || Part No. 465250
  • Tipo de evento
    Recall
  • ID del evento
    29096
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1152-04
  • Fecha de inicio del evento
    2003-12-17
  • Fecha de publicación del evento
    2004-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-08-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33130
  • 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
    Antistreptolysin - Titer/Streptolysin O Reagent - Product Code GTQ
  • Causa
    The aso (mpe) assayed in buffer cannot be programmed or calibrated using array calculator 5.
Retiro De Equipo (Recall) de Device Recall Nuclear, Magnetic Resonance Imaging
  • Tipo de evento
    Recall
  • ID del evento
    79451
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1432-2018
  • Fecha de inicio del evento
    2018-03-16
  • Fecha de publicación del evento
    2018-04-18
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162717
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Potential risk for helium gas inside the mr examination room during a magnet quench.
  • Acción
    On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm. **Action to be Taken by Customer**: During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use: Release of helium gas in the examination room" If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation. If helium enters the examination room: " Immediately remove all persons from the examination room. " Do not switch off air circulation and ventilation in the examination room. " Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level. "Emergency procedures" The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. (Instructions for Use R5.3) Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
Retiro De Equipo (Recall) de Device Recall Nuclear, Magnetic Resonance Imaging
  • Tipo de evento
    Recall
  • ID del evento
    79451
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1433-2018
  • Fecha de inicio del evento
    2018-03-16
  • Fecha de publicación del evento
    2018-04-18
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162718
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Potential risk for helium gas inside the mr examination room during a magnet quench.
  • Acción
    On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm. **Action to be Taken by Customer**: During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use: Release of helium gas in the examination room" If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation. If helium enters the examination room: " Immediately remove all persons from the examination room. " Do not switch off air circulation and ventilation in the examination room. " Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level. "Emergency procedures" The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. (Instructions for Use R5.3) Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
Retiro De Equipo (Recall) de LDL Cholesterol Reagent (LDLD) || Part No. 969706
  • Tipo de evento
    Recall
  • ID del evento
    29098
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-1099-04
  • Fecha de inicio del evento
    2003-02-10
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-12-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33132
  • 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, Low Density, Lipoprotein - Product Code MRR
  • Causa
    Expiration date on the reagent cartridges and kit box were incorrect in that they were about 6 months beyond the actual expiration date.
Retiro De Equipo (Recall) de Device Recall CryoValve
  • Tipo de evento
    Recall
  • ID del evento
    30803
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0581-05
  • Fecha de inicio del evento
    2004-12-17
  • Fecha de publicación del evento
    2005-03-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-01-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36630
  • 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
    Heart-Valve, Allograft - Product Code MIE
  • Causa
    Records noted that the infant donor's mother had tested positive for hepatitis b.
  • Acción
    Physicians were notified by letter on 12/17/2004.
Retiro De Equipo (Recall) de Device Recall Brilliance CT 16 Power Computed Tomography Xray systems
  • Tipo de evento
    Recall
  • ID del evento
    73750
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2370-2016
  • Fecha de inicio del evento
    2016-03-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144871
  • 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, x-ray, tomography, computed - Product Code JAK
  • Causa
    Software defect causing intermittently slow response of host.
  • Acción
    On 3/24/2016 the firm mailed Customer Information letters to their customers.
Retiro De Equipo (Recall) de Device Recall Ingenuity Core Computed Tomography Xray systems
  • Tipo de evento
    Recall
  • ID del evento
    73750
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2371-2016
  • Fecha de inicio del evento
    2016-03-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144872
  • 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, x-ray, tomography, computed - Product Code JAK
  • Causa
    Software defect causing intermittently slow response of host.
  • Acción
    On 3/24/2016 the firm mailed Customer Information letters to their customers.
Retiro De Equipo (Recall) de Device Recall Bac T/ALERT 3D Control Module
  • Tipo de evento
    Recall
  • ID del evento
    32377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0612-05
  • Fecha de inicio del evento
    2005-05-27
  • Fecha de publicación del evento
    2005-09-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39926
  • 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, Blood Culturing - Product Code MDB
  • Causa
    A bac t/alert 3d system failed to detect a positive sample in a pediatric bac t/alert pf bottle.
  • Acción
    Consignees were notified by letter on May 27, 2005.
Retiro De Equipo (Recall) de Device Recall Bac T/ALERT 3D Combination Module
  • Tipo de evento
    Recall
  • ID del evento
    32377
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0613-05
  • Fecha de inicio del evento
    2005-05-27
  • Fecha de publicación del evento
    2005-09-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-09-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39927
  • 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, Blood Culturing - Product Code MDB
  • Causa
    A bac t/alert 3d system failed to detect a positive sample in a pediatric bac t/alert pf bottle.
  • Acción
    Consignees were notified by letter on May 27, 2005.
Retiro De Equipo (Recall) de Device Recall Ingenuity Core 128 Computed Tomography Xray systems
  • Tipo de evento
    Recall
  • ID del evento
    73750
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2372-2016
  • Fecha de inicio del evento
    2016-03-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144873
  • 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, x-ray, tomography, computed - Product Code JAK
  • Causa
    Software defect causing intermittently slow response of host.
  • Acción
    On 3/24/2016 the firm mailed Customer Information letters to their customers.
Retiro De Equipo (Recall) de Device Recall Nuclear, Magnetic Resonance Imaging
  • Tipo de evento
    Recall
  • ID del evento
    79451
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1434-2018
  • Fecha de inicio del evento
    2018-03-16
  • Fecha de publicación del evento
    2018-04-18
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162719
  • 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, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Potential risk for helium gas inside the mr examination room during a magnet quench.
  • Acción
    On March 16, 2018, Philips Healthcare distributed URGENT MEDICAL DEVICE CORRECTION notices to their customers via certified mailing. On May 24, 2018, the recall letter was distributed to additional affected customers identified by the firm. **Action to be Taken by Customer**: During a quench, a large amount of helium evaporates and is vented outside the building through a venting system. A quench causes immediate removal of the static magnetic field. A quench can occur spontaneously or can be induced if there is an emergency. In case helium gas escapes into the examination room during a magnet quench ensure strict adherence to the Instructions for Use: Release of helium gas in the examination room" If helium gas is not vented properly after the Magnet Emergency Off button is used or during a quench (for example if the helium vent pipe is blocked) a high concentration of helium gas may build up in the examination room. This gas forms clouds of cold mist. Helium gas dilutes the oxygen in the air. High concentrations of helium gas can lead to suffocation. If helium enters the examination room: " Immediately remove all persons from the examination room. " Do not switch off air circulation and ventilation in the examination room. " Do not reenter the examination room until it is confirmed that the air oxygen content is at a safe level. "Emergency procedures" The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. (Instructions for Use R5.3) Philips will schedule an inspection of all MRI systems that may be affected by this notice. If applicable the spare metal burst disk on site will also be replaced during this inspection. Metal Burst disks on all aff
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