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  • Dispositivo 3
  • Fabricante 3
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Device Recall Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T...
  • Tipo de evento
    Recall
  • ID del evento
    68311
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1826-2014
  • Fecha de inicio del evento
    2014-05-15
  • Fecha de publicación del evento
    2014-06-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128082
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Ingenia customers have experienced clamping of the foot under the central column of the height adjustable flex trak trolley and the trolley variable height irf.
  • Acción
    Philips sent an Urgent Field Safety Notice (FSN78100414) dated May 2014 via certified mail to US and Canadian consignees. Philips Key Market representatives will distribute the letter internationally. The letter identified the affected product, explains the problem, actions that should be taken in order to prevent risks for users, and the actions planned by Philips to correct the problem. On May 31, 2014, Philips released a Field Change Order that requires service engineers to replace the front and rear covers of the Ingenia MR FlexTrak Trolley with new covers with protection bumper that prevents foot clamping. For further information and support concerning this issue, consignees should contact their local Philips representative at 1-800-722-9377.
Retiro De Equipo (Recall) de Device Recall Anspach Pneumatic and Electric Motor Systems
  • Tipo de evento
    Recall
  • ID del evento
    68496
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1983-2014
  • Fecha de inicio del evento
    2014-05-08
  • Fecha de publicación del evento
    2014-07-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-01-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128083
  • 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
    Instrument, surgical, orthopedic, pneumatic powered; accessory/attachment - Product Code HSZ
  • Causa
    Several attachments and handpieces failed to meet the expected sterility assurance level (sal) when sterilized by the method that is specified in the current directions for use (dfu) provided with the device.
  • Acción
    Customers were notified 05/08/2014 by a Return Receipt Requested letter from Anspach with an URGENT: Medical Device Labeling Correction announcement, REGARDING: STERRAD 100S Hydrogen Peroxide Gas Plasma Technology no longer recommended for sterilization of Anspach products. The letter identified the problem and actions to be taken by the customer. Customers were to complete and return the attached reply form. If the products were distributed further, then those customers should have been notified as well. Customers were to contact Anspach Customer Support at 1-800-327-6887 if they want copies of the revised labeling.
Retiro De Equipo (Recall) de Device Recall Trolley Variable Height IRF (for Ingenia 1.5T & 3.0T ...
  • Tipo de evento
    Recall
  • ID del evento
    68311
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1827-2014
  • Fecha de inicio del evento
    2014-05-15
  • Fecha de publicación del evento
    2014-06-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128084
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Causa
    Ingenia customers have experienced clamping of the foot under the central column of the height adjustable flex trak trolley and the trolley variable height irf.
  • Acción
    Philips sent an Urgent Field Safety Notice (FSN78100414) dated May 2014 via certified mail to US and Canadian consignees. Philips Key Market representatives will distribute the letter internationally. The letter identified the affected product, explains the problem, actions that should be taken in order to prevent risks for users, and the actions planned by Philips to correct the problem. On May 31, 2014, Philips released a Field Change Order that requires service engineers to replace the front and rear covers of the Ingenia MR FlexTrak Trolley with new covers with protection bumper that prevents foot clamping. For further information and support concerning this issue, consignees should contact their local Philips representative at 1-800-722-9377.
Retiro De Equipo (Recall) de Device Recall ANSAR ANX3.0 Autonomic Monitor system
  • Tipo de evento
    Recall
  • ID del evento
    68735
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2268-2014
  • Fecha de inicio del evento
    2014-07-01
  • Fecha de publicación del evento
    2014-08-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128581
  • 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
    Monitor, cardiac (incl. Cardiotachometer and rate alarm) - Product Code DRT
  • Causa
    The blood pressure (bp) circuit occasionally fails to inflate the blood pressure cuff and the bp circuit fails to activate, resulting in no bp measured.
  • Acción
    Recall notification letters sent to customers on July 8-9, 2014 by registered mail.
Retiro De Equipo (Recall) de Device Recall NewPort Spinal System
  • Tipo de evento
    Recall
  • ID del evento
    68498
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1961-2014
  • Fecha de inicio del evento
    2014-06-09
  • Fecha de publicación del evento
    2014-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128087
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Causa
    Integra lifesciences is recalling newport system mis rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter. this could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current newport mis system surgical technique.
  • Acción
    A customer notification letter was sent on 6/9/14 to their customers and distributors who purchased the Integra NewPort System MIS Rod, 2 to inform them there may be a potential that the hex on some NewPort System MIS Rod, 2 are up to 30 degrees offset from specification requirements causing misalignment with the inserter. Customers are instructed to complete and return the customer response form and return by email or fax as indicated on the form. Customers with questions are instructed to contact Customer Service at (866) 942-8698.
Retiro De Equipo (Recall) de Device Recall Stryker Orthopaedics Triathlon Tritanium Patella Inse...
  • Tipo de evento
    Recall
  • ID del evento
    68500
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1978-2014
  • Fecha de inicio del evento
    2014-05-01
  • Fecha de publicación del evento
    2014-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128089
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Tritanium patella inserter instrument fracture during implantation. .
  • Acción
    Stryker Orthopaedics issued an "Urgent Medical Device Recall Notification" letters/Notification Acknowledgement forms dated May 7, 2014 to their customers via Fed-Ex on May 7, 2014. The notification informs the customers of the issue(s) with the affected product; potential hazards; and how to identify and handle any affected product. Customers were instructed to return any affected product to Stryker Orthopaedics and fill out and return the enclosed Notification Acknowledgement form. For questions call (1-201-972-2100).
Retiro De Equipo (Recall) de Device Recall Medtronic Duet External Drainage and Monitoring System
  • Tipo de evento
    Recall
  • ID del evento
    68503
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1920-2014
  • Fecha de inicio del evento
    2014-06-09
  • Fecha de publicación del evento
    2014-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128099
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Causa
    Medtronic neurosurgery is recalling the medtronic duet external drainage and monitoring systems because the patient line tubing in the duet external drainage and monitoring systems may become disconnected from the patient line stopcock.
  • Acción
    An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
Retiro De Equipo (Recall) de Device Recall Medtronic Duet External Drainage and Monitoring System
  • Tipo de evento
    Recall
  • ID del evento
    68503
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1921-2014
  • Fecha de inicio del evento
    2014-06-09
  • Fecha de publicación del evento
    2014-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128100
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Causa
    Medtronic neurosurgery is recalling the medtronic duet external drainage and monitoring systems because the patient line tubing in the duet external drainage and monitoring systems may become disconnected from the patient line stopcock.
  • Acción
    An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
Retiro De Equipo (Recall) de Device Recall Medtronic Duet External Drainage and Monitoring System
  • Tipo de evento
    Recall
  • ID del evento
    68503
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1922-2014
  • Fecha de inicio del evento
    2014-06-09
  • Fecha de publicación del evento
    2014-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128101
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Causa
    Medtronic neurosurgery is recalling the medtronic duet external drainage and monitoring systems because the patient line tubing in the duet external drainage and monitoring systems may become disconnected from the patient line stopcock.
  • Acción
    An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
Retiro De Equipo (Recall) de Device Recall Medtronic Duet External Drainage and Monitoring System
  • Tipo de evento
    Recall
  • ID del evento
    68503
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1923-2014
  • Fecha de inicio del evento
    2014-06-09
  • Fecha de publicación del evento
    2014-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128102
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Causa
    Medtronic neurosurgery is recalling the medtronic duet external drainage and monitoring systems because the patient line tubing in the duet external drainage and monitoring systems may become disconnected from the patient line stopcock.
  • Acción
    An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
Retiro De Equipo (Recall) de Device Recall Medtronic Duet External Drainage and Monitoring System
  • Tipo de evento
    Recall
  • ID del evento
    68503
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1924-2014
  • Fecha de inicio del evento
    2014-06-09
  • Fecha de publicación del evento
    2014-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128103
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Causa
    Medtronic neurosurgery is recalling the medtronic duet external drainage and monitoring systems because the patient line tubing in the duet external drainage and monitoring systems may become disconnected from the patient line stopcock.
  • Acción
    An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
Retiro De Equipo (Recall) de Device Recall EXACTAMIX Compounder
  • Tipo de evento
    Recall
  • ID del evento
    68506
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1963-2014
  • Fecha de inicio del evento
    2014-06-10
  • Fecha de publicación del evento
    2014-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128106
  • 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
    Set, i.V. Fluid transfer - Product Code LHI
  • Causa
    If the universal ingredient (ui) in an active configuration is changed using the configuration editor, a flush of the outlet pump tube will not be initiated by the software. it could result in the original ui remaining in the tube which could be delivered into the next bag.
  • Acción
    An Urgent Device Correction communication via 1st class mail was mailed on July 14, 2014, informing customers of a potential issue if the universal ingredient in an active configuration is changed using the Configuration Editor rather than following the normally prescribed and supported methods as outlined in the Operator Manual.
Retiro De Equipo (Recall) de Device Recall Siemens Digital Linear Acceletators
  • Tipo de evento
    Recall
  • ID del evento
    68507
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2174-2014
  • Fecha de inicio del evento
    2014-05-28
  • Fecha de publicación del evento
    2014-08-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128108
  • 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
    Accelerator, linear, medical charged-particle radiation therapy system - Product Code IYE
  • Causa
    A safety risk exists with automatically sequenced treatment technique using the simtec auto field option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
  • Acción
    An Urgent Medical Device Correction Field Safety Notice Letter was sent to end users on/about June 2014 which described the product, problem, and actions to be taken to avoid encountering the safety risk to patients and users.
Retiro De Equipo (Recall) de Device Recall MIZUHO, MAL DISP DOPPLER PROBE
  • Tipo de evento
    Recall
  • ID del evento
    68512
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1998-2014
  • Fecha de inicio del evento
    2014-05-28
  • Fecha de publicación del evento
    2014-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128114
  • 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
    Flowmeter, blood, cardiovascular - Product Code DPW
  • Causa
    Report of the product penetrating the sterile barrier; this could render the product unsterile.
  • Acción
    Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient. Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used. For further questions please call (603) 594-9700.
Retiro De Equipo (Recall) de Device Recall MIZUHO, DOPPLER PROBE, SLIM
  • Tipo de evento
    Recall
  • ID del evento
    68512
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1999-2014
  • Fecha de inicio del evento
    2014-05-28
  • Fecha de publicación del evento
    2014-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128115
  • 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
    Flowmeter, blood, cardiovascular - Product Code DPW
  • Causa
    Report of the product penetrating the sterile barrier; this could render the product unsterile.
  • Acción
    Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient. Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used. For further questions please call (603) 594-9700.
Retiro De Equipo (Recall) de Device Recall MIZUHO, MINI, SLIM, STERILE
  • Tipo de evento
    Recall
  • ID del evento
    68512
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2000-2014
  • Fecha de inicio del evento
    2014-05-28
  • Fecha de publicación del evento
    2014-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128117
  • 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
    Flowmeter, blood, cardiovascular - Product Code DPW
  • Causa
    Report of the product penetrating the sterile barrier; this could render the product unsterile.
  • Acción
    Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient. Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used. For further questions please call (603) 594-9700.
Retiro De Equipo (Recall) de Device Recall VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE
  • Tipo de evento
    Recall
  • ID del evento
    68512
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2001-2014
  • Fecha de inicio del evento
    2014-05-28
  • Fecha de publicación del evento
    2014-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128118
  • 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
    Flowmeter, blood, cardiovascular - Product Code DPW
  • Causa
    Report of the product penetrating the sterile barrier; this could render the product unsterile.
  • Acción
    Vascular Technology sent an Urgent Medical Device Recall letter dated May 28, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This recall has been initiated due to a report of the product penetrating the sterile barrier; this could render the product unsterile. Use of this product may lead to infection in the patient. Please immediately examine your inventory and return all product subject to recall to Vascular Technology at the above mentioned address. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customer must include instructions telling your customer to return the recalled product if unused or to account for the recalled product if it has been used. For further questions please call (603) 594-9700.
Retiro De Equipo (Recall) de Device Recall Sarns SoftFlow Aortic Cannulae
  • Tipo de evento
    Recall
  • ID del evento
    68404
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2105-2014
  • Fecha de inicio del evento
    2014-05-23
  • Fecha de publicación del evento
    2014-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128126
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Causa
    During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications.
  • Acción
    Terumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow the packing instructions to return the affected product, and 5. Terumo CVS will issue credit once the affected units are returned. For questions call Terumo CVS c/o Stericycle 1-866-629-6181.
Retiro De Equipo (Recall) de Device Recall MicroScan WalkAway40 plus Instrument and MicroScan Wa...
  • Tipo de evento
    Recall
  • ID del evento
    68524
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1990-2014
  • Fecha de inicio del evento
    2014-06-02
  • Fecha de publicación del evento
    2014-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-12-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128140
  • 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
    Instrument for auto reader & interpretation of overnight suscept. Systems - Product Code LRG
  • Causa
    Springs contained in the access door hinge assembly on the walk away plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.
  • Acción
    Urgent Medical Device Recall notification letter was sent to all affected US customers on June 2nd by Federal Express. OUS notifications were also sent to regional Siemens organizations who distributed in-country notifications and relevant notifications.
Retiro De Equipo (Recall) de Device Recall CPB Catheter Kit
  • Tipo de evento
    Recall
  • ID del evento
    68404
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2106-2014
  • Fecha de inicio del evento
    2014-05-23
  • Fecha de publicación del evento
    2014-07-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128128
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Causa
    During an in-process inspection, terumo cardiovascular systems (terumo cvs) identified the presence of loose fiber particulate that exceeded finished product specifications.
  • Acción
    Terumo sent an Urgent Medical Device Recall letters dated June 27, 2014 to their customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Review this Medical Device Recall notice, 2. Assure that all users in your institution have received notice of this issue and remove any affected units from use, 3. Fill out the Product Tracking Sheet (enclosed), indicating the number of affected units at your institution and fax to 1-877-907-7509 or email to terumo4967@stericycle.com. 4. Complete the Packing Slip (enclosed) and follow the packing instructions to return the affected product, and 5. Terumo CVS will issue credit once the affected units are returned. For questions call Terumo CVS c/o Stericycle 1-866-629-6181.
Retiro De Equipo (Recall) de Device Recall Integra
  • Tipo de evento
    Recall
  • ID del evento
    68519
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1976-2014
  • Fecha de inicio del evento
    2014-06-11
  • Fecha de publicación del evento
    2014-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128129
  • 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
    Headlamp, operating, battery-operated - Product Code HPP
  • Causa
    Led battery chargers may prematurely fail and will not charge the led battery as intended.
  • Acción
    Integra initiated a voluntary recall on June 11, 2014 to consignees that have been shipped affected product lots of Integra¿ LED Battery Chargers, Catalogue No. 90523. The written notifications were delivered to US consignees by traceable courier service and non-US consignees by traceable email or facsimile. The consignee notification: Advises them of the nature of the issue and the potential for an adverse patient consequence. Advises them to review their inventory and how to determine if they have affected battery chargers. Advises them to immediately stop the use or distribution of any affected product lot numbers they may have. Requests they identify and report to Integra if they do or do not have any unexpired affected product lots. Advises them replacements battery chargers will be shipped for any affected products they affirm are in their possession and how to return their affected product. Questions regarding these instructions, please contact Integra Customer Service at 1-800-431-1123 or your Integra sales
Retiro De Equipo (Recall) de Device Recall ADVIA Centaur Systems TnlUltra assay
  • Tipo de evento
    Recall
  • ID del evento
    68520
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1991-2014
  • Fecha de inicio del evento
    2014-05-30
  • Fecha de publicación del evento
    2014-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128130
  • 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
    Immunoassay method, troponin subunit - Product Code MMI
  • Causa
    The solid phase reagent in some of the advia centaur¿ tni -ultra readypacks¿, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
  • Acción
    An Urgent medical Device Correction (UMDC) was mailed, via FedEx, to all affected Siemens Healthcare Diagnostics customers in the United States on May 30, 2014 for customer receipt on June 2, 2014. All international customers were provided with a copy of the Urgent Field Safety Notice via hard copy, e-mail, and/or fax as determined by each country's local regulations and procedures. Each customer is asked to complete a fax-back form. This notice informed the customers of the potential for incorrect control and patient results due to solid phase which is darker in appearance. The notice instructs customers to place one TnI-Ultra ReadyPack on the system at a time and to calibrate and run controls on each ReadyPack to ensure accurate control and patient values. Patient TnI-Ultra results produced with this assay are acceptable if they follow acceptable calibration with valid quality control results. Upon receipt of kit lots ending in 086 and higher, calibration of each ReadyPack is not required. This notice should be reviewed with the facility's laboratory or medical director.
Retiro De Equipo (Recall) de Device Recall UltraStream Chronic Hemodialysis Catheter
  • Tipo de evento
    Recall
  • ID del evento
    68521
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2696-2014
  • Fecha de inicio del evento
    2014-06-05
  • Fecha de publicación del evento
    2014-09-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128132
  • 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, hemodialysis, implanted - Product Code MSD
  • Causa
    Ultrastream chronic hemodialysis catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Retiro De Equipo (Recall) de Device Recall UltraStream Exchange Kit
  • Tipo de evento
    Recall
  • ID del evento
    68521
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2697-2014
  • Fecha de inicio del evento
    2014-06-05
  • Fecha de publicación del evento
    2014-09-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128133
  • 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, hemodialysis, implanted - Product Code MSD
  • Causa
    Ultrastream chronic hemodialysis catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Retiro De Equipo (Recall) de Device Recall UltraStream Peel Away Kit
  • Tipo de evento
    Recall
  • ID del evento
    68521
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2698-2014
  • Fecha de inicio del evento
    2014-06-05
  • Fecha de publicación del evento
    2014-09-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128134
  • 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, hemodialysis, implanted - Product Code MSD
  • Causa
    Ultrastream chronic hemodialysis catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
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