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  • Dispositivo 193
  • Fabricante 46
  • Evento 124969
  • Implante 11
Retiro De Equipo (Recall) de VNUS 7F ClosureFAST Catheter
  • Tipo de evento
    Recall
  • ID del evento
    45510
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0542-2008
  • Fecha de inicio del evento
    2007-08-08
  • Fecha de publicación del evento
    2008-01-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65695
  • 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 - Product Code GEI
  • Causa
    Instructions for use change: instructions for use have been changed to include a modified placement recommendation.
  • Acción
    The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.
Retiro De Equipo (Recall) de Varian RPM System version 1.7.3
  • Tipo de evento
    Recall
  • ID del evento
    45519
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0554-2008
  • Fecha de publicación del evento
    2008-01-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-09-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65722
  • 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
    Linear Medical Accelerator - Product Code IYE
  • Causa
    Erroneously resetting: rpm system version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. rpm 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the session options during the treatment session. this can lead to difference between the planned and delivered.
  • Acción
    Varian sent an Urgent Medical Device Correction letter on September 26, 2007, to all its direct consignees, informing them that the RPM version 1.7 may reset the phase thresholds if Sessions options are accessed during treatment. A Service Representative will be scheduling a visit to user site to perform the modification requested to address the problem, when a corrected software version is available.
Retiro De Equipo (Recall) de Medtronic SynchroMed EL
  • Tipo de evento
    Recall
  • ID del evento
    45595
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0950-2008
  • Fecha de inicio del evento
    2007-08-03
  • Fecha de publicación del evento
    2008-02-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65823
  • 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
    Pump, Infusion, Implanted, Programmable - Product Code LKK
  • Causa
    Pump motor stall; pumps can stall due to gear shaft wear.
  • Acción
    Begining August 3, 2007, consignees were notified by letter. The letter "Medtronic Urgent: Medical Device Correction Aug 2007" described the problem and the Affected Devices as well as Patient Risk, Patient Management Recommendations, Next Steps and Physician and Patient Support.
Retiro De Equipo (Recall) de SERFAS Energy Suction Probe
  • Tipo de evento
    Recall
  • ID del evento
    45822
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0484-2008
  • Fecha de inicio del evento
    2007-04-26
  • Fecha de publicación del evento
    2008-01-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-01-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66216
  • 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
    Electrosurgical Cutting Device - Product Code GEI
  • Causa
    Device shut off/on: device may not turn off after taking finger/foot off of activating switch and may activate without pushing a button. (patient burns may result from these device malfunctions).
  • Acción
    Consignees were mailed an Urgent Device Removal Recall notice, dated April 27, 2007. International subsidiaries will receive the recall notice and they will distribute to their consignees. Product is to be returned as a recall.
Retiro De Equipo (Recall) de VNUS 7F ClosureFAST Catheter
  • Tipo de evento
    Recall
  • ID del evento
    45510
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0543-2008
  • Fecha de inicio del evento
    2007-08-08
  • Fecha de publicación del evento
    2008-01-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66271
  • 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 - Product Code GEI
  • Causa
    Instructions for use change: instructions for use have been changed to include a modified placement recommendation.
  • Acción
    The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.
Retiro De Equipo (Recall) de External Bone Fixation System
  • Tipo de evento
    Recall
  • ID del evento
    45878
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0674-2008
  • Fecha de publicación del evento
    2008-02-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66393
  • 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
    bone distractor - Product Code LXT
  • Causa
    Markings reversed: graduated markings on telescoping bone distractors were reversed, causing the distractors to compress rather than distract the treatment site when adjusted.
  • Acción
    Orthofix notified sales agents by phone starting on 09/28/07. Sales agents were to return product for replacements.
Retiro De Equipo (Recall) de Synchron LX20 Clinical Chemistry System
  • Tipo de evento
    Recall
  • ID del evento
    45960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1094-2008
  • Fecha de inicio del evento
    2007-04-05
  • Fecha de publicación del evento
    2008-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66581
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Causa
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Acción
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
Retiro De Equipo (Recall) de Synchron LX20 PRO Clinical Chemistry System
  • Tipo de evento
    Recall
  • ID del evento
    45960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1095-2008
  • Fecha de inicio del evento
    2007-04-05
  • Fecha de publicación del evento
    2008-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66582
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Causa
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Acción
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
Retiro De Equipo (Recall) de Synchron LXi 725 Clinical Chemistry System
  • Tipo de evento
    Recall
  • ID del evento
    45960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1096-2008
  • Fecha de inicio del evento
    2007-04-05
  • Fecha de publicación del evento
    2008-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66583
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Causa
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Acción
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
Retiro De Equipo (Recall) de Hipstar V40 Femoral Stem
  • Tipo de evento
    Recall
  • ID del evento
    45334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0469-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66611
  • 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
    Femoral Stem - Product Code LPH
  • Causa
    Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Acción
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
Retiro De Equipo (Recall) de UniCel DxC 600
  • Tipo de evento
    Recall
  • ID del evento
    45960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1097-2008
  • Fecha de inicio del evento
    2007-04-05
  • Fecha de publicación del evento
    2008-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66584
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Causa
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Acción
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
Retiro De Equipo (Recall) de UniCel DxC 600i
  • Tipo de evento
    Recall
  • ID del evento
    45960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1098-2008
  • Fecha de inicio del evento
    2007-04-05
  • Fecha de publicación del evento
    2008-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66585
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Causa
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Acción
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
Retiro De Equipo (Recall) de UniCel DxC 600 PRO
  • Tipo de evento
    Recall
  • ID del evento
    45960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1099-2008
  • Fecha de inicio del evento
    2007-04-05
  • Fecha de publicación del evento
    2008-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66586
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Causa
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Acción
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
Retiro De Equipo (Recall) de UniCel DxC 800
  • Tipo de evento
    Recall
  • ID del evento
    45960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1100-2008
  • Fecha de inicio del evento
    2007-04-05
  • Fecha de publicación del evento
    2008-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66588
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Causa
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Acción
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
Retiro De Equipo (Recall) de UniCel DxC 800 PRO
  • Tipo de evento
    Recall
  • ID del evento
    45960
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1101-2008
  • Fecha de inicio del evento
    2007-04-05
  • Fecha de publicación del evento
    2008-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66589
  • 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
    Chemistry Analyzer (Discrete Photometric) - Product Code JJE
  • Causa
    Intermittent failure of stirrer motor-beckman coulter has determined that incorrect glucose results on lx20 or dxc instruments have been related to an intermittent failure of the stirrer motor. -stirrer motors can stall without any flags or motion errors. -if a stall occurs during a glum test near the time of sample inject, results may be affected. -affected glum results may be high or low.
  • Acción
    GLUm stir motors greater than one year old were replaced. Replacements began April 5, 2007. Based on the Risk Assessment, BCI decided that Customer Notification is not needed. GLUm stir motors greater than one year old will be replaced on high volume LX/DxC systems by 3rd quarter of 2007. Replacements began April 5, 2007. A new stirrer design is being developed and is expected to be available before 4th quarter of 2007. Implementation Strategy of Stock Control: 1. A Stop Ship was not necessary based on risk assessment. The possibility of stirrer motor failure may increase with time and duty cycles. Systems running a high volume of tests may have a greater likelihood of exhibiting stirrer motor failure with motors greater than one year old. 2. New Customers were placed on a preventative maintenance plan to have their motor replaced at one year cycle. Completed 3. A Technical Update was issued to notify Hotline and Field Service Personnel of the issues.
Retiro De Equipo (Recall) de Hipstar TMZF
  • Tipo de evento
    Recall
  • ID del evento
    45982
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0475-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-09-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66604
  • 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
    Hip Stem Protocol - Product Code LPH
  • Causa
    Mis-labeling: an error on page 4 of the hipstar protocol was found. in the table for compatible heads, the 40 mm diameter heads with a neck length of +12 should have been omitted.
  • Acción
    Urgent Product Correction Letters, dated 10/17/2007 were sent on 10/17/07by Federal Express to all Stryker Branches/Agencies who had received the protocol. The branches were instructed to quarantine and destroy the protocols.
Retiro De Equipo (Recall) de Hipstar V40 Femoral Stem
  • Tipo de evento
    Recall
  • ID del evento
    45334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0464-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66606
  • 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
    Femoral Stem - Product Code LPH
  • Causa
    Mis-labeling; the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Acción
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
Retiro De Equipo (Recall) de Hipstar V40 Femoral Stem
  • Tipo de evento
    Recall
  • ID del evento
    45334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0465-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66607
  • 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
    Femoral Stem - Product Code LPH
  • Causa
    Mis-labeling; the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Acción
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
Retiro De Equipo (Recall) de Hipstar V40 Femoral Stem
  • Tipo de evento
    Recall
  • ID del evento
    45334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0466-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66608
  • 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
    Femoral Stem - Product Code LPH
  • Causa
    Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Acción
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
Retiro De Equipo (Recall) de Hipstar V40 Femoral Stem
  • Tipo de evento
    Recall
  • ID del evento
    45334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0467-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66609
  • 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
    Femoral Stem - Product Code LPH
  • Causa
    Mis-labeling; the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Acción
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
Retiro De Equipo (Recall) de Hipstar V40 Femoral Stem
  • Tipo de evento
    Recall
  • ID del evento
    45334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0468-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66610
  • 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
    Femoral Stem - Product Code LPH
  • Causa
    Mis-labeling; the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Acción
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
Retiro De Equipo (Recall) de Hipstar V40 Femoral Stem
  • Tipo de evento
    Recall
  • ID del evento
    45334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0470-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66612
  • 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
    Femoral Stem - Product Code LPH
  • Causa
    Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Acción
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
Retiro De Equipo (Recall) de Hipstar V40 Femoral Stem
  • Tipo de evento
    Recall
  • ID del evento
    45334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0471-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66613
  • 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
    Femoral Stem - Product Code LPH
  • Causa
    Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Acción
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
Retiro De Equipo (Recall) de Hipstar V40 Femoral Stem
  • Tipo de evento
    Recall
  • ID del evento
    45334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0472-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66614
  • 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
    Femoral Stem - Product Code LPH
  • Causa
    Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Acción
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
Retiro De Equipo (Recall) de Hipstar V40 Femoral Stem
  • Tipo de evento
    Recall
  • ID del evento
    45334
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0473-2008
  • Fecha de publicación del evento
    2007-12-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66615
  • 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
    Femoral Stem - Product Code LPH
  • Causa
    Mis-labeling: the warning label "do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.
  • Acción
    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.
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