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  • Dispositivo 42
  • Fabricante 18
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Intersept Custom Tubing Pack
  • Tipo de evento
    Recall
  • ID del evento
    37079
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0583-2007
  • Fecha de inicio del evento
    2007-01-02
  • Fecha de publicación del evento
    2007-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49877
  • 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
    custom tubing pack for cardiopulmonary bypass - Product Code DWE
  • Causa
    One lot of custom perfusion sets, catalog 2t10r1 was incorrectly assembled. the one way vacuum relief valve on the 102 inch line is attached backwards, thus preventing flow.
  • Acción
    There was only one customer. The customer was sent a letter on December 29, 2006, requesting that the impacted product be disposed of or returned to Medtronic for disposal.
Retiro De Equipo (Recall) de Device Recall Cytomics FC 500
  • Tipo de evento
    Recall
  • ID del evento
    37083
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0418-2007
  • Fecha de inicio del evento
    2006-08-29
  • Fecha de publicación del evento
    2007-02-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49884
  • 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
    cell analyzer - Product Code GKZ
  • Causa
    Two workflow scenarios associated with renaming regions may produce incorrect results.
  • Acción
    A Product Corrective Action (PCA) letter was sent on the week of August 29, 2006 to all accounts that have an FC500 or have ordered CXP or MXP software to inform them that a) incorrect statistics are generated when a polygonal region with vertical re-entrant vertices is renamed using the Region Properties dialog box. b)when a region is copied from one plot to another, and then the new region is renamed, the statistics are not updated with the new region name. (Letter was sent by US mail). Letter includes immediate user preventive action to remedy both issues. A response form is included for consignees to return to recalling firm.
Retiro De Equipo (Recall) de Device Recall Sara Active Sling Narrow
  • Tipo de evento
    Recall
  • ID del evento
    37085
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0424-2007
  • Fecha de inicio del evento
    2007-01-09
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49887
  • 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
    patient lift - Product Code FSA
  • Causa
    There is the potential for the slings to come apart, potentially allowing injury to the patient.
  • Acción
    Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/9/07 via FedEx to the end user accounts who received the affected slings, advising them of the potential for the slings to come apart. They were instructed to remove the affected slings from use and replace them with the slings enclosed with the letter, complete the enclosed customer response form, and return the form and the original recalled slings, using the pre-paid call tag provided. If they have any questions or require additional, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140.
Retiro De Equipo (Recall) de Device Recall Sara Active Sling Wide
  • Tipo de evento
    Recall
  • ID del evento
    37085
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0425-2007
  • Fecha de inicio del evento
    2007-01-09
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49891
  • 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
    patient lift - Product Code FSA
  • Causa
    There is the potential for the slings to come apart, potentially allowing injury to the patient.
  • Acción
    Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/9/07 via FedEx to the end user accounts who received the affected slings, advising them of the potential for the slings to come apart. They were instructed to remove the affected slings from use and replace them with the slings enclosed with the letter, complete the enclosed customer response form, and return the form and the original recalled slings, using the pre-paid call tag provided. If they have any questions or require additional, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140.
Retiro De Equipo (Recall) de Device Recall Sara Active Sling Standard
  • Tipo de evento
    Recall
  • ID del evento
    37085
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0426-2007
  • Fecha de inicio del evento
    2007-01-09
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-09-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49892
  • 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
    patient lift - Product Code FSA
  • Causa
    There is the potential for the slings to come apart, potentially allowing injury to the patient.
  • Acción
    Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/9/07 via FedEx to the end user accounts who received the affected slings, advising them of the potential for the slings to come apart. They were instructed to remove the affected slings from use and replace them with the slings enclosed with the letter, complete the enclosed customer response form, and return the form and the original recalled slings, using the pre-paid call tag provided. If they have any questions or require additional, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140.
Retiro De Equipo (Recall) de Device Recall SERVOi
  • Tipo de evento
    Recall
  • ID del evento
    37089
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0372-2007
  • Fecha de inicio del evento
    2006-05-23
  • Fecha de publicación del evento
    2007-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-04-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49893
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    ventilator - Product Code CBK
  • Causa
    Reported failures of the servo-i ventilators user interface system causing technical errors and increased fault frequencies. switches may be activated unintentionally, or a function not activate when the switch is selected. direct access knobs may not function or change the parameter in the wrong direction compared to how they are turned.
  • Acción
    Maquet sent an ''Extended Warranty'' letter on May 23, 2006. On March 13, 2007, Maquet issued a Recall Notification letter to all customers stating that they will replace all PC1777 boards in the serial number range 2400-3300, which have not previously been replaced. A safety alert letter was included outlining the failure indication and effect for the user of the failures, as well as, how to identify whether the Servo-i unit has shown any failure indications.
Retiro De Equipo (Recall) de Device Recall D10 Dual Program
  • Tipo de evento
    Recall
  • ID del evento
    37097
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0376-2007
  • Fecha de inicio del evento
    2006-11-17
  • Fecha de publicación del evento
    2007-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49903
  • 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
    in vitro diagnostic - Product Code JIT
  • Causa
    The diluent in the d-10 dual program calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.
  • Acción
    The firm has issued phone calls and faxes to its US consignees starting 11/17/2006 and International notices began on 11/20/2006 explaining the reason for the recall and requesting the product be disposed.
Retiro De Equipo (Recall) de Device Recall Maquet Critical Care Ventilator System
  • Tipo de evento
    Recall
  • ID del evento
    37099
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0379-2007
  • Fecha de inicio del evento
    2006-05-23
  • Fecha de publicación del evento
    2007-02-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49905
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Ventilator System - Product Code CBK
  • Causa
    The connection of certain nebulizers to the built in driver has lead to reduced or no nebulization effect on the servo-i ventilator.
  • Acción
    Maquet Critical Care issued an ''Extended Warranty'' letter on 5/23/2006. On March 13, 2007, Maquet modified its recall strategy and issued a Recall Notification letter accompanied by a Safety Alert letter to all customers with Servo-i ventilators, serial numbers in the 14000-22772 range, with Servo nebulizer installed. The Safety Alert letter provides customers with information on how to identify if the unit is affected, and how to identify if the unit has shown any failures, as well as, any precautions. Firm initiated recall is on-going
Retiro De Equipo (Recall) de Device Recall Cook Antimicrobial Catheter
  • Tipo de evento
    Recall
  • ID del evento
    37102
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0637-2007
  • Fecha de inicio del evento
    2007-01-02
  • Fecha de publicación del evento
    2007-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49916
  • 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 FOZ
  • Causa
    These catheters do not include the proximal sidehole as required by the specification.
  • Acción
    Consignees were notified by phone on 1/2/07 and instructed to return the product.
Retiro De Equipo (Recall) de Device Recall Cytomics FC 500 MPL
  • Tipo de evento
    Recall
  • ID del evento
    37083
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0419-2007
  • Fecha de inicio del evento
    2006-08-29
  • Fecha de publicación del evento
    2007-02-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49917
  • 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
    cell analyzer - Product Code GKZ
  • Causa
    Two workflow scenarios associated with renaming regions may produce incorrect results.
  • Acción
    A Product Corrective Action (PCA) letter was sent on the week of August 29, 2006 to all accounts that have an FC500 or have ordered CXP or MXP software to inform them that a) incorrect statistics are generated when a polygonal region with vertical re-entrant vertices is renamed using the Region Properties dialog box. b)when a region is copied from one plot to another, and then the new region is renamed, the statistics are not updated with the new region name. (Letter was sent by US mail). Letter includes immediate user preventive action to remedy both issues. A response form is included for consignees to return to recalling firm.
Retiro De Equipo (Recall) de Device Recall Terumo perfusion cannulae
  • Tipo de evento
    Recall
  • ID del evento
    37104
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0543-2007
  • Fecha de inicio del evento
    2006-12-07
  • Fecha de publicación del evento
    2007-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49919
  • 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
    arterial perfusion cannulae - Product Code DWF
  • Causa
    The cannula connector is an incorrect size: it is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".
  • Acción
    Consignee was notified via telephone on 12/7/06 and returned the product.
Retiro De Equipo (Recall) de Device Recall Terumo perfusion cannulae
  • Tipo de evento
    Recall
  • ID del evento
    37104
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0544-2007
  • Fecha de inicio del evento
    2006-12-07
  • Fecha de publicación del evento
    2007-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49920
  • 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
    arterial perfusion cannulae - Product Code DWF
  • Causa
    The cannula connector is an incorrect size: it is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".
  • Acción
    Consignee was notified via telephone on 12/7/06 and returned the product.
Retiro De Equipo (Recall) de Device Recall Engstrom Carestation
  • Tipo de evento
    Recall
  • ID del evento
    37105
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0784-2007
  • Fecha de inicio del evento
    2007-02-02
  • Fecha de publicación del evento
    2007-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49921
  • 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
    Critical Care Ventilator - Product Code CBK
  • Causa
    There are two unique conditions with the engstrom carestation that require corrective action. these include an anomaly in the control of the safety relief valve and a situation where the display unit may reset.
  • Acción
    Device Correction Letter to customers was mailed on 2/2/07 giving information about the correction and a short term recommendation until version 4.15 could be installed by a GE representative who would be contacting the customer.
Retiro De Equipo (Recall) de Device Recall AMS 700 Penile Prothesis
  • Tipo de evento
    Recall
  • ID del evento
    37437
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0788-2007
  • Fecha de inicio del evento
    2007-02-09
  • Fecha de publicación del evento
    2007-05-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50561
  • 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
    Penile Prothesis - Product Code JCW
  • Causa
    The carton labeling does not match the product packaged inside.
  • Acción
    AMS has contacted every account (via e-mail 2/9/2007) that either purchased or implanted the affected product. Unused pieces have been recovered and scrapped.
Retiro De Equipo (Recall) de Device Recall HoMedics Thera P Heating pad
  • Tipo de evento
    Recall
  • ID del evento
    37106
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0622-2007
  • Fecha de inicio del evento
    2007-02-09
  • Fecha de publicación del evento
    2007-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49923
  • 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
    Heating Pad - Product Code IRT
  • Causa
    Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
  • Acción
    Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of the recall.
Retiro De Equipo (Recall) de Device Recall HoMedics Thera P heating pad
  • Tipo de evento
    Recall
  • ID del evento
    37106
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0623-2007
  • Fecha de inicio del evento
    2007-02-09
  • Fecha de publicación del evento
    2007-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49924
  • 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
    Heating Pad - Product Code IRT
  • Causa
    Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
  • Acción
    Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of the recall.
Retiro De Equipo (Recall) de Device Recall HoMedics Thera P heating pad
  • Tipo de evento
    Recall
  • ID del evento
    37106
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0624-2007
  • Fecha de inicio del evento
    2007-02-09
  • Fecha de publicación del evento
    2007-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49925
  • 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
    Heating Pad - Product Code IRT
  • Causa
    Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
  • Acción
    Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of the recall.
Retiro De Equipo (Recall) de Device Recall HoMedics Thera P Heating pad
  • Tipo de evento
    Recall
  • ID del evento
    37106
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0625-2007
  • Fecha de inicio del evento
    2007-02-09
  • Fecha de publicación del evento
    2007-03-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49926
  • 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
    Heating Pad - Product Code IRT
  • Causa
    Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
  • Acción
    Press release issued on 2/9/07 instructing consumers to return the product to store of purchase or Homedics. Retail stores notified via recall letter issued on 2/9/07. Retail stores are being instructed to accept returns and to post placards to notify customers of the recall.
Retiro De Equipo (Recall) de Device Recall OOptix (lotrafilcon B) Soft Contact Lenses
  • Tipo de evento
    Recall
  • ID del evento
    37113
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0427-2007
  • Fecha de inicio del evento
    2007-01-11
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49932
  • 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
    Soft Contact Lenses - Product Code LPM
  • Causa
    Reduced ion permeability.
  • Acción
    Consignees were notified by traceable mail on 01/12/2007. Consignees were advised to locate any of the affected lots and return them to CIBA Vision in accordance with the attached instructions. Returned lenses will be destroyed.
Retiro De Equipo (Recall) de Device Recall Cook Flexor DL
  • Tipo de evento
    Recall
  • ID del evento
    37115
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0377-2007
  • Fecha de inicio del evento
    2007-01-05
  • Fecha de publicación del evento
    2007-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49934
  • 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
    endoscope - Product Code FED
  • Causa
    Lack of assurance of sterility, as the packages may not have been sealed.
  • Acción
    Consignees were notified via recall letter dated 1/5/07 and requested to return the product.
Retiro De Equipo (Recall) de Device Recall Skytron Infinity series (also called Astro series) mi...
  • Tipo de evento
    Recall
  • ID del evento
    37120
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0524-2007
  • Fecha de inicio del evento
    2007-01-08
  • Fecha de publicación del evento
    2007-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49939
  • 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
    surgical light - Product Code FTD
  • Causa
    If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
  • Acción
    The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.
Retiro De Equipo (Recall) de Device Recall AMS 700 Penile Prothesis
  • Tipo de evento
    Recall
  • ID del evento
    37437
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0789-2007
  • Fecha de inicio del evento
    2007-02-09
  • Fecha de publicación del evento
    2007-05-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50563
  • 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
    Penile Prothesis - Product Code JCW
  • Causa
    The carton labeling does not match the product packaged inside.
  • Acción
    AMS has contacted every account (via e-mail 2/9/2007) that either purchased or implanted the affected product. Unused pieces have been recovered and scrapped.
Retiro De Equipo (Recall) de Device Recall Skytron Infinity series (also called Astro series) mi...
  • Tipo de evento
    Recall
  • ID del evento
    37120
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0525-2007
  • Fecha de inicio del evento
    2007-01-08
  • Fecha de publicación del evento
    2007-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49940
  • 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
    surgical light - Product Code FTD
  • Causa
    If the mounting plug is improperly adjusted, the unit could separate, come apart, and fall from the mount.
  • Acción
    The firm initially notified consignees of this problem on 11/23/1999 and again on 11/01/2002 and most lights have already been corrected. Remaining consignees with lights in need of correction were notified of the problem via letter dated 1/8/07 and instructed to contact the distributor to have their lights inspected and modified.
Retiro De Equipo (Recall) de Device Recall GE Centricity PACS RA1000 Workstation
  • Tipo de evento
    Recall
  • ID del evento
    37121
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0373-2007
  • Fecha de inicio del evento
    2007-01-12
  • Fecha de publicación del evento
    2007-01-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49945
  • 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
    diagnostic image analysis - Product Code LLZ
  • Causa
    The centricity pacs ra1000 workstation software may manifest certain mammography image display problems only if the images were acquired through ge senographe versions 2000d, ds or essential.
  • Acción
    GE Healthcare IITS sent recall letters dated 1/12/07 to all customers who have the combination of GE Centricity PACS RA1000 Workstation software versions 2.1.X.X, or 3.0.X.X combined with the GE Senographe 2000D, the Senographe DS, or Senographe Essential mammography scanners, informing them that the entire breast image or a portion of the breast image may not be displayed in the monitor regions and may not be evident to the end-user. To mitigate this problem, the users were provided a Quick Reference Guide detailing how to use the Pan tool to move the image left, right, up and down in order to display any portion of the image that may not be displayed on the screen. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the issues and understand the risk mitigation provided. A software patch to permanently resolve the issue will be installed at no charge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-437-1171.
Retiro De Equipo (Recall) de Device Recall Boston Scientific iLab
  • Tipo de evento
    Recall
  • ID del evento
    37126
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0395-2007
  • Fecha de inicio del evento
    2006-12-01
  • Fecha de publicación del evento
    2007-02-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49950
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    ultrasound - Product Code DQO
  • Causa
    The product fails to comply with applicable electronic product performance standard, in that the electromagnetic energy is in excess of the labeled conformance standards for radiated emissions.
  • Acción
    A customer notification was sent December 1, 2006 indicating the need for the correction.
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