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  • Dispositivo 3
  • Fabricante 3
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall GE LightSpeed Computed Tomography
  • Tipo de evento
    Recall
  • ID del evento
    37007
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0805-2007
  • Fecha de inicio del evento
    2006-12-21
  • Fecha de publicación del evento
    2007-05-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50034
  • 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
    CT Scanner - Product Code JAK
  • Causa
    Oil may leak onto the port window of the ct tube and may result in image artifacts that could lead to misdiagnosis.
  • Acción
    A Field Modification Instruction was issued to the field to inspect all systems and replace the tube window screws and the window filter, as well as clean any traces of oil in the tube window area. A 12/21/2006, Urgent Product Correction Notice/Customer letter has also been distributed informing the customers of the safety issue and the product correction.
Retiro De Equipo (Recall) de Device Recall Discovery VCT, Volume PETCT scanner
  • Tipo de evento
    Recall
  • ID del evento
    37007
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0806-2007
  • Fecha de inicio del evento
    2006-12-21
  • Fecha de publicación del evento
    2007-05-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50036
  • 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
    PET-CT Scanner - Product Code JAK
  • Causa
    Oil may leak onto the port window of the ct tube and may result in image artifacts that could lead to misdiagnosis.
  • Acción
    A Field Modification Instruction was issued to the field to inspect all systems and replace the tube window screws and the window filter, as well as clean any traces of oil in the tube window area. A 12/21/2006, Urgent Product Correction Notice/Customer letter has also been distributed informing the customers of the safety issue and the product correction.
Retiro De Equipo (Recall) de Device Recall Abiomed
  • Tipo de evento
    Recall
  • ID del evento
    37170
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0574-2007
  • Fecha de inicio del evento
    2007-01-08
  • Fecha de publicación del evento
    2007-03-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50038
  • 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
    Circulatory Support System - Product Code DSQ
  • Causa
    Unit may alarm ''low flow'' and ''low pressure'' due to manufacturing material in the pressure source.
  • Acción
    Abiomed notified customers by letter dated 1/08/07. Service reps will inspect units and replace the defective components.
Retiro De Equipo (Recall) de Device Recall Candela Corporation Vbeam Aesthetica Laser System
  • Tipo de evento
    Recall
  • ID del evento
    37180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0508-2007
  • Fecha de inicio del evento
    2007-01-15
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50053
  • 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
    Laser System - Product Code GEX
  • Causa
    Internal component may overheat causing the possibility of risk of fire or smoke.
  • Acción
    Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.
Retiro De Equipo (Recall) de Device Recall Candela Corporation Vbeam Aesthetica Laser System
  • Tipo de evento
    Recall
  • ID del evento
    37180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0509-2007
  • Fecha de inicio del evento
    2007-01-15
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50056
  • 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
    Laser System - Product Code GEX
  • Causa
    Internal component may overheat causing the possibility of risk of fire or smoke.
  • Acción
    Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.
Retiro De Equipo (Recall) de Device Recall Candela Corporation Vbeam Aesthetica Laser System
  • Tipo de evento
    Recall
  • ID del evento
    37180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0510-2007
  • Fecha de inicio del evento
    2007-01-15
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50057
  • 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
    Laser System - Product Code GEX
  • Causa
    Internal component may overheat causing the possibility of risk of fire or smoke.
  • Acción
    Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.
Retiro De Equipo (Recall) de Device Recall Candela Corporation Vbeam Aesthetica Laser System
  • Tipo de evento
    Recall
  • ID del evento
    37180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0511-2007
  • Fecha de inicio del evento
    2007-01-15
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50058
  • 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
    Laser System - Product Code GEX
  • Causa
    Internal component may overheat causing the possibility of risk of fire or smoke.
  • Acción
    Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.
Retiro De Equipo (Recall) de Device Recall Candela Corporation Vbeam Aesthetica Laser System
  • Tipo de evento
    Recall
  • ID del evento
    37180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0512-2007
  • Fecha de inicio del evento
    2007-01-15
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50059
  • 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
    Laser System - Product Code GEX
  • Causa
    Internal component may overheat causing the possibility of risk of fire or smoke.
  • Acción
    Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.
Retiro De Equipo (Recall) de Device Recall Candela Corporation Vbeam Aesthetica Laser System
  • Tipo de evento
    Recall
  • ID del evento
    37180
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0513-2007
  • Fecha de inicio del evento
    2007-01-15
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50060
  • 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
    Laser System - Product Code GEX
  • Causa
    Internal component may overheat causing the possibility of risk of fire or smoke.
  • Acción
    Candela Corporation notified US consignees by letter (w/return receipt) identifying the potential problem on 1/17/2007. Candela services will contact the customers and schedule upgrades. International packages were sent to each distributor via Fed-x/DHL tracking on 1/17/2007. Distributors were asked to forward individual serial number packages to their customers. Upgrade material will be forwarded to distributors upon which they will schedule upgrades with their customers.
Retiro De Equipo (Recall) de Device Recall BlackMax Motor System
  • Tipo de evento
    Recall
  • ID del evento
    37183
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1039-2008
  • Fecha de inicio del evento
    2006-12-18
  • Fecha de publicación del evento
    2008-02-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50061
  • 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 ENT Drill - Product Code ERL
  • Causa
    Incorrect sterilization process --the operating manual for the product contains an incorrect statement regarding the sterilization of the autolube foot control. the manual states that the product can withstand eto sterilization, but there is no data to support this process.
  • Acción
    Anspach issued an Urgent Device Correction letter on 11/27/06, to all manual holders advising them of the error and requested that they update the manual with the corrected instructions. A reply receipt confirming notification was included.
Retiro De Equipo (Recall) de Device Recall Taut Intraducer Peritoneal Catheter
  • Tipo de evento
    Recall
  • ID del evento
    37182
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0428-2007
  • Fecha de inicio del evento
    2007-01-19
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-08-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50062
  • 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
    Peritoneal Catheter - Product Code GBW
  • Causa
    Taut, inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.
  • Acción
    Taut sent Urgent Medical Device Recall letters dated 1/19/07, via UPS over night, on the same date, informing them that the two lots of catheters may have package seals that are not intact. Customers were instructed to check their stocks for the affected lots, remove any found and return all affected product immediately. The PI-128 is also a component of the System One Comprehensive Lap CBDE Kist, catalog number 50000, which is a convenience kit. The customer is being instructed to remove the PI-128, Intraducer Peritoneal Catheter contained in the System Once Comprehensive Lap CBDE Kit in the eight kit lots listed, and return the PI-128 catheters. All other components of the kit may be used. As the PI-128, Intraducer Peritoneal Catheter, can also be ordered as a replacement component, the customer is also being instructed to check all opened System One Comprehensive lap CBDE kits, regardless of lot number, to ensure that it does not contain the impacted PI-128 lots. The customers were requested to complete and return the enclosed Acknowledgment & Stock Status Form, which includes an option to obtain replacement product for the PI-128, immediately faxing it back to Linda Todd at 919-433-4986. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Retiro De Equipo (Recall) de Device Recall Drager Medical Air Compressor
  • Tipo de evento
    Recall
  • ID del evento
    37188
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0674-2007
  • Fecha de inicio del evento
    2007-01-26
  • Fecha de publicación del evento
    2007-04-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50072
  • 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 Air Compressor - Product Code BTI
  • Causa
    Compressors not providing sufficient supply pressure to connected medical ventilator.
  • Acción
    The recalling firm issued a Medical Device Recall Letter dated 1/22/07 to their customers via Certified Mail. An authorized service representative will inspect each potentially affected device. If a device is found to have an affected dryer assembly, it will be repaired free of charge.
Retiro De Equipo (Recall) de Device Recall DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder
  • Tipo de evento
    Recall
  • ID del evento
    37189
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0731-2007
  • Fecha de inicio del evento
    2007-01-24
  • Fecha de publicación del evento
    2007-04-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-08-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50073
  • 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
    Oxygen cylinders - Product Code NFB
  • Causa
    Cylinder could lose oxygen at high pressure after the filling process.
  • Acción
    The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.
Retiro De Equipo (Recall) de Device Recall Imageintensified fluoroscopic xray system.
  • Tipo de evento
    Recall
  • ID del evento
    37191
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0514-2007
  • Fecha de inicio del evento
    2007-01-15
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50074
  • 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
    fluoroscopic x-ray system - Product Code JAA
  • Causa
    Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall.
  • Acción
    Consignees were notified by letter on 01/15/2007. Instructions were given to position and not move the dual monitors until inspection and correction by GE personnel. For the affected units with a 3 phase power distribution box, users were cautioned to ensure that the access door to the power box is completely closed when the unit is powered on to prevent a shock hazard.
Retiro De Equipo (Recall) de Device Recall Alsius Cool Line
  • Tipo de evento
    Recall
  • ID del evento
    37192
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0502-2007
  • Fecha de inicio del evento
    2007-01-01
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50075
  • 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 Thermal Regulation System - Product Code NCX
  • Causa
    Testing by alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.
  • Acción
    Customer letters were sent starting January 1, 2006 via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt . The Customer letters will notify consignees of the nature of the problem and provide instructions to return the product.
Retiro De Equipo (Recall) de Device Recall Alsius Cool Line
  • Tipo de evento
    Recall
  • ID del evento
    37192
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0503-2007
  • Fecha de inicio del evento
    2007-01-01
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-06-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50079
  • 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 Thermal Regulation System - Product Code NCX
  • Causa
    Testing by alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.
  • Acción
    Customer letters were sent starting January 1, 2006 via FEDEX and DHL. Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt . The Customer letters will notify consignees of the nature of the problem and provide instructions to return the product.
Retiro De Equipo (Recall) de Device Recall Quantum TTC Biliary Balloon Dilation Catheter
  • Tipo de evento
    Recall
  • ID del evento
    37213
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0520-2007
  • Fecha de inicio del evento
    2007-01-24
  • Fecha de publicación del evento
    2007-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-07-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50117
  • 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
    Balloon Dilator - Product Code KNQ
  • Causa
    The graphic label is incorrect, it lists 6mm/ 18fr. the product label is correct, it lists 10mm/ 30fr.
  • Acción
    Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.
Retiro De Equipo (Recall) de Device Recall AcrySof ReSTOR Intraocular Lens
  • Tipo de evento
    Recall
  • ID del evento
    37009
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0430-2007
  • Fecha de inicio del evento
    2006-12-14
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-04-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50118
  • 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
    Intraocular Lens - Product Code MFK
  • Causa
    Intraocular lenses exposed to extreme temperatures while in storage.
  • Acción
    The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006.
Retiro De Equipo (Recall) de Device Recall AcrySof Intraocular Lens
  • Tipo de evento
    Recall
  • ID del evento
    37009
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0431-2007
  • Fecha de inicio del evento
    2006-12-14
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-04-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50119
  • 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
    Intraocular Lens - Product Code MFK
  • Causa
    Intraocular lenses exposed to extreme temperatures while in storage.
  • Acción
    The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006.
Retiro De Equipo (Recall) de Device Recall Stryker stretcher, Model 660.
  • Tipo de evento
    Recall
  • ID del evento
    37214
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0219-2008
  • Fecha de inicio del evento
    2004-11-15
  • Fecha de publicación del evento
    2007-11-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50120
  • 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
    Stretcher - Product Code FPO
  • Causa
    The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.
  • Acción
    The firm issued an Urgent Medical Device Correction Letter dated 9/24/07, to each consignee informing them of the problems, that the brakes on each affected stretcher needed to be inspected/tested and removed from service if brake problems were discovered, and that a Stryker service representative would be in contact to replace the brakes.
Retiro De Equipo (Recall) de Device Recall Imageintensified fluoroscopic xray system.
  • Tipo de evento
    Recall
  • ID del evento
    37191
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0515-2007
  • Fecha de inicio del evento
    2007-01-15
  • Fecha de publicación del evento
    2007-02-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50129
  • 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
    fluoroscopic x-ray system - Product Code JAA
  • Causa
    Uroview 2800 system with 3 phase power distribution box (wonder box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on. .
  • Acción
    Consignees were notified by letter on 01/15/2007. Instructions were given to position and not move the dual monitors until inspection and correction by GE personnel. For the affected units with a 3 phase power distribution box, users were cautioned to ensure that the access door to the power box is completely closed when the unit is powered on to prevent a shock hazard.
Retiro De Equipo (Recall) de Device Recall Smith & Nephew
  • Tipo de evento
    Recall
  • ID del evento
    37232
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0662-2007
  • Fecha de inicio del evento
    2007-01-19
  • Fecha de publicación del evento
    2007-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-01-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50150
  • 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
    Probe, Radiofrequency Lesion - Product Code GXI
  • Causa
    Product is non-sterile but labeled incorrectly as sterile.
  • Acción
    Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007
Retiro De Equipo (Recall) de Device Recall Symbia S Series SPECT System with a Pinhole Collimator
  • Tipo de evento
    Recall
  • ID del evento
    37231
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0548-2007
  • Fecha de inicio del evento
    2007-01-30
  • Fecha de publicación del evento
    2007-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-11-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50151
  • 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
    Single-Photon Emission Computed Tomography - Product Code KPS
  • Causa
    Symbia systems, running on e.Soft version 5.5 or earlier, could allow a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage.
  • Acción
    Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 1/30/07 to all users of Symbia systems with a pinhole collimator and e.soft software versions 5.5 or earlier. The accounts were informed of the potential for a fully-extended patient pallet to come into contact with the pinhole collimator, resulting in system damage. The customers were advised that a Siemens Customer Service Representative would be sent to their site to upgrade their system software to version syngeo MI Applications 2006A within 30 days. The upgrade will be done free of charge.
Retiro De Equipo (Recall) de Device Recall Smith & Nephew
  • Tipo de evento
    Recall
  • ID del evento
    37232
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0663-2007
  • Fecha de inicio del evento
    2007-01-19
  • Fecha de publicación del evento
    2007-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-01-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50152
  • 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
    Probe, Radiofrequency Lesion - Product Code GXI
  • Causa
    Product is non-sterile but labeled incorrectly as sterile.
  • Acción
    Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007
Retiro De Equipo (Recall) de Device Recall Smith & Nephew
  • Tipo de evento
    Recall
  • ID del evento
    37232
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0664-2007
  • Fecha de inicio del evento
    2007-01-19
  • Fecha de publicación del evento
    2007-03-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-01-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50153
  • 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
    Probe, Radiofrequency Lesion - Product Code GXI
  • Causa
    Product is non-sterile but labeled incorrectly as sterile.
  • Acción
    Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007
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