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  • Dispositivo 193
  • Fabricante 46
  • Evento 124969
  • Implante 11
Retiro De Equipo (Recall) de Device Recall BBL CDC Anaerobe 5 Sheep Blood Agar.
  • Tipo de evento
    Recall
  • ID del evento
    64883
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1334-2013
  • Fecha de inicio del evento
    2013-03-11
  • Fecha de publicación del evento
    2013-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117274
  • 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
    Culture media, non-selective and non-differential - Product Code JSG
  • Causa
    Microbiological media may be contaminated with bacteria.
  • Acción
    BD Diagnostics notified consignees with a "Field Correction Notification" sent on 3/11/13 to distributors, direct accounts, and distributors' customers as available, via fax and email, and followed by a letter sent via UPS. The notice identified the product, the problem, and the action to be taken by customers. BD Diagnostic Systems informed customers of the bacterial contamination of some microbiological media, including BBL Trypticase Soy Agar with 5% Sheep's blood, part number 221239, lot 2348199; part number 221261, lots 2339019, 2348108, 2348208, 2348074, 2348157, 2355145, 2348202, and 2361011; BBL Trypticase Soy Agar with 5% Sheep's blood plus MacConkey II-I plate, part number 221291, lots 2355138 and 2355164; and BBL CDC Anaerobe 5% Sheep blood agar, lot 2361003. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians. The notice included a response form to indicate receipt of the notice. BD Diagnostic Systems contacted distributors and end-users via fax, email, and letter on 4/25/13 to notify them of a recall expansion to include lot 3038371 from part/catalog number 221261. The recall notice included an acknowledgement form to document receipt. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians.
Retiro De Equipo (Recall) de Device Recall GemStar Infusion System
  • Tipo de evento
    Recall
  • ID del evento
    64839
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1160-2013
  • Fecha de inicio del evento
    2013-03-18
  • Fecha de publicación del evento
    2013-04-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117195
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.
  • Acción
    Hospira sent an Urgent Device Field Correction letter dated March 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form to Stericycle. Lithium batteries that are older than three (3) years should be replaced. Customers should contact their Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, to determine if their battery need to be replaced and if necessary, arrange for the return of their device to perform battery replacement. Customers with questions should call 1-877-907-7516. For questions regarding this recall call 224-212-4892.
Retiro De Equipo (Recall) de Device Recall GemStar Infusion System
  • Tipo de evento
    Recall
  • ID del evento
    64837
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1170-2013
  • Fecha de inicio del evento
    2013-03-18
  • Fecha de publicación del evento
    2013-04-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117216
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    Pump shutting off during use without warning.
  • Acción
    Hospira sent an Important Device Information letter dated March 18, 2013, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect the affected product for signs of leakage, corrosion or other damage prior to each use. In addition, each time the batteries are replaced the battery compartment should be inspected for damage. If a device exhibits damage caused by leakage, it should immediately be removed from clinical service and Hospira should be contacted at 1-800-441-4100 to arrange for return of the device for repair. If the product has been further distributed they should notify their consignees and confirm they have done so by returning the reply form to Stericycle. For questions regarding this recall call 224-212-4892.
Retiro De Equipo (Recall) de Device Recall Gemstar Infusion System
  • Tipo de evento
    Recall
  • ID del evento
    64832
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0350-2014
  • Fecha de inicio del evento
    2013-03-15
  • Fecha de publicación del evento
    2013-11-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117221
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Pump, infusion - Product Code FRN
  • Causa
    The proximal and distal pressure sensor calibration can drift resulting in the pump failing the proximal or distal occlusion operational test, as described in the gemstar technical service manual, or reporting one of the following errors during device setup or infusion: 1) cassette check - d; 2) cassette check - p; 3) proximal occlusion; 4) distal occlusion; 5) pressure calibration error; 6) bad pressure sensor event; 7) bad pressure state; 8) distal pressure is out of range; 9) proximal sensor is out of range. a pump with this issue may, instead of reporting an error, not detected occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user.
  • Acción
    Hospira sent an Urgent Device Field Correction letter dated March 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter asks that customers immediately perform proximal and distal occlusion tests as defined i nthe GemStar Technical Service Manual. If the device fails either of the tests, remove it from clinical service and contact Hospira at 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM) to report the issue and arrange for the return of the device for recalibration. The letter further reminds customers that the proximal and distal occlusion tests should be performed on an annual basis as a part of the yearly GemStar maintenance schedule. Customers were also requested to complete and return the attached reply form and return it to Hospira by fax to 1-888-714-5077 or by e-mail to Hospira7906@stericycle.com. Customers were directed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form to Stericycle. For questions regarding this recall call 800-441-4100.
Retiro De Equipo (Recall) de Device Recall AMS 800 Urinary Control System.
  • Tipo de evento
    Recall
  • ID del evento
    64875
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1279-2013
  • Fecha de inicio del evento
    2013-03-01
  • Fecha de publicación del evento
    2013-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117226
  • 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
    Device, incontinence, mechanical/hydraulic - Product Code EZY
  • Causa
    American medical systems, inc. is initiating a recall on two components of the ams 800¿ urinary control system, control pump & pressure-regulating balloon. these products were released despite not meeting all final product release criteria.
  • Acción
    American Medical Systems sent two written communications distributed within the United States. The first is a letter that is being delivered to customers who purchased the affected lots using their ship to address from the original sales order. The second is a letter being delivered to implanting physician customers who are known by AMS to be regular users of the devices. Similar letters will be sent to international customers, including both end users and distributors (where applicable). American Medical Systems sent a "Urgent Medical Device Recall" letter dated February 28, 2013, to all affected customers. The letters identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to return the recalled product and to complete the Product Recall Acknowledgement Form. The letters addressed to "Physicians" advised consignees against prophylactic removal of implanted control pumps and pressure-regulating balloons contained within the scope of the product recall. For further questions please call AMS Customer Service at 1 (800) 328-3881
Retiro De Equipo (Recall) de Device Recall 3mm Diamond Ball
  • Tipo de evento
    Recall
  • ID del evento
    64886
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1377-2013
  • Fecha de inicio del evento
    2011-03-04
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117275
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Causa
    Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
  • Acción
    Anspach sent an URGENT: Medical Device Correction letter dated March 4, 2011 to its customers identifying the affected product and actions to be taken by the customers. Customers questions or concerns should be directed to Anspach Customer Support at (800) 327-6887.
Retiro De Equipo (Recall) de Device Recall AMS 800 Urinary Control System
  • Tipo de evento
    Recall
  • ID del evento
    64875
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1280-2013
  • Fecha de inicio del evento
    2013-03-01
  • Fecha de publicación del evento
    2013-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117227
  • 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
    Device, incontinence, mechanical/hydraulic - Product Code EZY
  • Causa
    American medical systems, inc. is initiating a recall on two components of the ams 800¿ urinary control system, control pump & pressure-regulating balloon. these products were released despite not meeting all final product release criteria.
  • Acción
    American Medical Systems sent two written communications distributed within the United States. The first is a letter that is being delivered to customers who purchased the affected lots using their ship to address from the original sales order. The second is a letter being delivered to implanting physician customers who are known by AMS to be regular users of the devices. Similar letters will be sent to international customers, including both end users and distributors (where applicable). American Medical Systems sent a "Urgent Medical Device Recall" letter dated February 28, 2013, to all affected customers. The letters identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to return the recalled product and to complete the Product Recall Acknowledgement Form. The letters addressed to "Physicians" advised consignees against prophylactic removal of implanted control pumps and pressure-regulating balloons contained within the scope of the product recall. For further questions please call AMS Customer Service at 1 (800) 328-3881
Retiro De Equipo (Recall) de Device Recall MSK EXTREME MR SCANNER
  • Tipo de evento
    Recall
  • ID del evento
    64885
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1211-2013
  • Fecha de inicio del evento
    2013-03-28
  • Fecha de publicación del evento
    2013-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117258
  • 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
    Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
  • Acción
    GE Healthcare sent an Urgent Medical Device Correction letter dated April 23, 2013, to all affected customers. The letter informed customers of a potential safety issue due to leakage from gradient coolant lines. Consignees were instructed to monitor the floor for leakage and continue to use if leakage is not observed. If leakage is observed consignees are instructed to stop using the system and notify their local service representative. GE Healthcare will correct all affected scanners by providing an update at no cost. Customers with questions were instructed to contact their local service representataive. For questions regarding this recall call 262-513-4122.
Retiro De Equipo (Recall) de Device Recall Optima MR430s MRI Scanner
  • Tipo de evento
    Recall
  • ID del evento
    64885
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1212-2013
  • Fecha de inicio del evento
    2013-03-28
  • Fecha de publicación del evento
    2013-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117262
  • 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
    Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
  • Acción
    GE Healthcare sent an Urgent Medical Device Correction letter dated April 23, 2013, to all affected customers. The letter informed customers of a potential safety issue due to leakage from gradient coolant lines. Consignees were instructed to monitor the floor for leakage and continue to use if leakage is not observed. If leakage is observed consignees are instructed to stop using the system and notify their local service representative. GE Healthcare will correct all affected scanners by providing an update at no cost. Customers with questions were instructed to contact their local service representataive. For questions regarding this recall call 262-513-4122.
Retiro De Equipo (Recall) de Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood
  • Tipo de evento
    Recall
  • ID del evento
    64883
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1332-2013
  • Fecha de inicio del evento
    2013-03-11
  • Fecha de publicación del evento
    2013-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117272
  • 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
    Culture media, non-selective and non-differential - Product Code JSG
  • Causa
    Microbiological media may be contaminated with bacteria.
  • Acción
    BD Diagnostics notified consignees with a "Field Correction Notification" sent on 3/11/13 to distributors, direct accounts, and distributors' customers as available, via fax and email, and followed by a letter sent via UPS. The notice identified the product, the problem, and the action to be taken by customers. BD Diagnostic Systems informed customers of the bacterial contamination of some microbiological media, including BBL Trypticase Soy Agar with 5% Sheep's blood, part number 221239, lot 2348199; part number 221261, lots 2339019, 2348108, 2348208, 2348074, 2348157, 2355145, 2348202, and 2361011; BBL Trypticase Soy Agar with 5% Sheep's blood plus MacConkey II-I plate, part number 221291, lots 2355138 and 2355164; and BBL CDC Anaerobe 5% Sheep blood agar, lot 2361003. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians. The notice included a response form to indicate receipt of the notice. BD Diagnostic Systems contacted distributors and end-users via fax, email, and letter on 4/25/13 to notify them of a recall expansion to include lot 3038371 from part/catalog number 221261. The recall notice included an acknowledgement form to document receipt. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians.
Retiro De Equipo (Recall) de Device Recall BBL Trypticase Soy Agar with 5 Sheep Blood and MacCon...
  • Tipo de evento
    Recall
  • ID del evento
    64883
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1333-2013
  • Fecha de inicio del evento
    2013-03-11
  • Fecha de publicación del evento
    2013-05-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117273
  • 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
    Culture media, selective and differential - Product Code JSI
  • Causa
    Microbiological media may be contaminated with bacteria.
  • Acción
    BD Diagnostics notified consignees with a "Field Correction Notification" sent on 3/11/13 to distributors, direct accounts, and distributors' customers as available, via fax and email, and followed by a letter sent via UPS. The notice identified the product, the problem, and the action to be taken by customers. BD Diagnostic Systems informed customers of the bacterial contamination of some microbiological media, including BBL Trypticase Soy Agar with 5% Sheep's blood, part number 221239, lot 2348199; part number 221261, lots 2339019, 2348108, 2348208, 2348074, 2348157, 2355145, 2348202, and 2361011; BBL Trypticase Soy Agar with 5% Sheep's blood plus MacConkey II-I plate, part number 221291, lots 2355138 and 2355164; and BBL CDC Anaerobe 5% Sheep blood agar, lot 2361003. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians. The notice included a response form to indicate receipt of the notice. BD Diagnostic Systems contacted distributors and end-users via fax, email, and letter on 4/25/13 to notify them of a recall expansion to include lot 3038371 from part/catalog number 221261. The recall notice included an acknowledgement form to document receipt. The notice instructed customers to follow product insert directions for inspecting media before use to identify and eliminate contaminated media, and to verify Listeria findings with clinicians.
Retiro De Equipo (Recall) de Device Recall Insight Instruments MIS ( MultiPort Illumination System)
  • Tipo de evento
    Recall
  • ID del evento
    64887
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1281-2013
  • Fecha de inicio del evento
    2013-03-15
  • Fecha de publicación del evento
    2013-05-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-21
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117276
  • 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
    Cannula, Ophthalmic - Product Code HMX
  • Causa
    Insight instruments, inc., stuart, fl is recalling m.I.S. (multi-port illumination system), ophthalmic cannula due to a misclassification of the medical device.
  • Acción
    Insight Instruments, Inc. sent a recall letter dated March 15, 2013, to all affected customers The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to do the following: 1)Perform a physical count of their inventory immediately for any of the recalled lots and complete and return the Return Response Form. 2) If they have any products listed, contact the firm at (800) 255-8354, to arrange for return and prompt replacement. 3) Discontinue using and dispensing all M.I.S. devices of the recalled lots.
Retiro De Equipo (Recall) de Device Recall HealthLinkBIOPSY PUNCHES
  • Tipo de evento
    Recall
  • ID del evento
    64888
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1654-2013
  • Fecha de inicio del evento
    2013-03-18
  • Fecha de publicación del evento
    2013-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117277
  • 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
    Punch, surgical - Product Code LRY
  • Causa
    Due to lack of sterilization.
  • Acción
    On March 19, 2013, HealthLink sent their customers letters instructing them to do the following: 1) Screen their inventory and quarantine the product. 2) Notify all customers that received the affected products and ask them to return the lots to their firm. 3) Complete the attached form and return the lots to HealthLink Distribution center. For further assistance, customers were directed to call customer service at 1-800-638-2625.
Retiro De Equipo (Recall) de Device Recall GE, VCT for Discovery VCT, Discovery RX VCT, and Disc...
  • Tipo de evento
    Recall
  • ID del evento
    64889
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1188-2013
  • Fecha de inicio del evento
    2011-07-25
  • Fecha de publicación del evento
    2013-04-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117278
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, x-ray, tomography, computed - Product Code JAK
  • Causa
    Fastener bolts on the heat exchanger were not properly torqued and part of the heat exchanger can detach from the gantry and hit the inside of the covers and other components of the gantry possibly resulting in the oil conduit breaking, spilling oil within the gantry and outside the system. this issue affects ge healthcare vct for discovery vct, discovery rx vct, and discovery pet/ct 690, lightspe.
  • Acción
    No consignee letter was sent out. At customer site Field Engineer replaced heat exchanger, the tube and the pump. Field Engineer also verified torque on all bolts. Field action was initiated on 7/25/2011 and has been completed as of 3/29/2013.
Retiro De Equipo (Recall) de Device Recall GE Healthcare, AW Server.
  • Tipo de evento
    Recall
  • ID del evento
    64900
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1137-2013
  • Fecha de inicio del evento
    2012-06-28
  • Fecha de publicación del evento
    2013-04-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117349
  • 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, image processing, radiological - Product Code LLZ
  • Causa
    Ge healthcare has recently become aware of a potential safety issue with respect to the results viewer in the aw server. after starting the results viewer with the selected series of a patient, the pixel and certain annotation data from a different patient is displayed in one of the viewports. this occurs on an occasional basis, when multiple users are simultaneously accessing the results viewe.
  • Acción
    GE Healthcare sent an "Important Product Information" letter dated June 27, 2012. The letter was addressed to Hospital Administrators , Radiology Managers and Risk Managers. The letter described the Subject, Instructions and Affected Product Details. GE Healthcare will correct all affected product by providing a software upgrade at no cost. For questions call: US 800-437-1171, Japan 0120-055-919, and/or local GE Healthcare Service Representative.
Retiro De Equipo (Recall) de Device Recall MobileDiagnost wDR
  • Tipo de evento
    Recall
  • ID del evento
    64902
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1706-2017
  • Fecha de inicio del evento
    2012-11-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117359
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, x-ray, mobile - Product Code IZL
  • Causa
    When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.
  • Acción
    Philips Medicals Systems distributed an "URGENT Field Safety Notice" alerting customers of the defect on November 28, 2012. Customers are requested to manually rotate images by using the rotation tool.Customers are also recommended to check whether the automatic marker is set correctly, especially after a manual image rotation is performed. The marker can be corrected manually with the annotation tool.
Retiro De Equipo (Recall) de Device Recall Discovery MR750, Discovery 450, Optima 450W (with and...
  • Tipo de evento
    Recall
  • ID del evento
    64918
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1207-2013
  • Fecha de inicio del evento
    2012-06-08
  • Fecha de publicación del evento
    2013-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117394
  • 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
    Ge healthcare has recently become aware of a reformat image flip issue associated with ge mr products. the axial and coronal reformatted images from a sagittal 3d series (such as with applications of fspgr-3d t1, bravo t1, or cube t1) of over 126 slices may display a left-to-right image flip . in addition, the acquired sagittal images may be annotated with left-right location annotation revers.
  • Acción
    GE Healthcare sent an "Important Product Information" letter dated June 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their local service representative for questions regarding this notice.
Retiro De Equipo (Recall) de Device Recall GE 1.5T SIGNA HDe MR SYSTEM
  • Tipo de evento
    Recall
  • ID del evento
    64918
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1208-2013
  • Fecha de inicio del evento
    2012-06-08
  • Fecha de publicación del evento
    2013-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117398
  • 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
    Ge healthcare has recently become aware of a reformat image flip issue associated with ge mr products. the axial and coronal reformatted images from a sagittal 3d series (such as with applications of fspgr-3d t1, bravo t1, or cube t1) of over 126 slices may display a left-to-right image flip . in addition, the acquired sagittal images may be annotated with left-right location annotation revers.
  • Acción
    GE Healthcare sent an "Important Product Information" letter dated June 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their local service representative for questions regarding this notice.
Retiro De Equipo (Recall) de Device Recall Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovati...
  • Tipo de evento
    Recall
  • ID del evento
    64918
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1209-2013
  • Fecha de inicio del evento
    2012-06-08
  • Fecha de publicación del evento
    2013-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117400
  • 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
    Ge healthcare has recently become aware of a reformat image flip issue associated with ge mr products. the axial and coronal reformatted images from a sagittal 3d series (such as with applications of fspgr-3d t1, bravo t1, or cube t1) of over 126 slices may display a left-to-right image flip . in addition, the acquired sagittal images may be annotated with left-right location annotation revers.
  • Acción
    GE Healthcare sent an "Important Product Information" letter dated June 8, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers should contact their local service representative for questions regarding this notice.
Retiro De Equipo (Recall) de Device Recall MediChoice Rayon Tipped OB/GYN Applicator
  • Tipo de evento
    Recall
  • ID del evento
    64919
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1192-2013
  • Fecha de inicio del evento
    2013-03-26
  • Fecha de publicación del evento
    2013-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117406
  • 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
    Applicator, absorbent tipped, non-sterile - Product Code KXF
  • Causa
    Owens & minor distribution, inc. is conducting a market withdrawal of medichoice applicator ob-gyn 8 inch product that does not meet our quality standards because the rayon may loosen or unravel from the applicator during use.
  • Acción
    Owens&Minor; sent an Urgent: Medical Device Recall letter to the first set of customers on March 26, 2013 and to their second set of customers on April 9, 2013. The letter identified the affect product, problem and actions to be taken. Customers were instructed to examine their inventory and quarantine all affected products, contact service representative to discuss whether affected products should be returned or destroyed, and complete and return the Recall Reply Form. For questions call 804-723-7417.
Retiro De Equipo (Recall) de Device Recall Baxter
  • Tipo de evento
    Recall
  • ID del evento
    64928
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2471-2015
  • Fecha de inicio del evento
    2013-02-25
  • Fecha de publicación del evento
    2015-08-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117439
  • 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, administration, for peritoneal dialysis, disposable - Product Code KDJ
  • Causa
    Labeling revision: additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
  • Acción
    Baxter sent an IMPORTANT PRODUCT INFORMATION letters dated February 25, 2013 to affected customers via USPS. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached reply form and return it to Baxter by faxing it to 224-270-5457 of scanning the form and e-mailing it to fca@baxter.com. For general questions about this communication can be answered by contacting The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST). Clinical questions can be answered by calling Baxter's Renal Division Clinic Help line at 888-736-2543 x 2 (Monday - Friday, 8:00 AM - 5:00 PM CST).
Retiro De Equipo (Recall) de Device Recall Baxter
  • Tipo de evento
    Recall
  • ID del evento
    64928
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2472-2015
  • Fecha de inicio del evento
    2013-02-25
  • Fecha de publicación del evento
    2015-08-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117440
  • 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, administration, for peritoneal dialysis, disposable - Product Code KDJ
  • Causa
    Labeling revision: additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
  • Acción
    Baxter sent an IMPORTANT PRODUCT INFORMATION letters dated February 25, 2013 to affected customers via USPS. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached reply form and return it to Baxter by faxing it to 224-270-5457 of scanning the form and e-mailing it to fca@baxter.com. For general questions about this communication can be answered by contacting The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST). Clinical questions can be answered by calling Baxter's Renal Division Clinic Help line at 888-736-2543 x 2 (Monday - Friday, 8:00 AM - 5:00 PM CST).
Retiro De Equipo (Recall) de Device Recall Baxter
  • Tipo de evento
    Recall
  • ID del evento
    64928
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2473-2015
  • Fecha de inicio del evento
    2013-02-25
  • Fecha de publicación del evento
    2015-08-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117442
  • 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, administration, for peritoneal dialysis, disposable - Product Code KDJ
  • Causa
    Labeling revision: additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
  • Acción
    Baxter sent an IMPORTANT PRODUCT INFORMATION letters dated February 25, 2013 to affected customers via USPS. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached reply form and return it to Baxter by faxing it to 224-270-5457 of scanning the form and e-mailing it to fca@baxter.com. For general questions about this communication can be answered by contacting The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST). Clinical questions can be answered by calling Baxter's Renal Division Clinic Help line at 888-736-2543 x 2 (Monday - Friday, 8:00 AM - 5:00 PM CST).
Retiro De Equipo (Recall) de Device Recall 5C4160 Transfer Set with Spike Connector
  • Tipo de evento
    Recall
  • ID del evento
    64928
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2474-2015
  • Fecha de inicio del evento
    2013-02-25
  • Fecha de publicación del evento
    2015-08-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117443
  • 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, administration, for peritoneal dialysis, disposable - Product Code KDJ
  • Causa
    Labeling revision: additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
  • Acción
    Baxter sent an IMPORTANT PRODUCT INFORMATION letters dated February 25, 2013 to affected customers via USPS. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached reply form and return it to Baxter by faxing it to 224-270-5457 of scanning the form and e-mailing it to fca@baxter.com. For general questions about this communication can be answered by contacting The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST). Clinical questions can be answered by calling Baxter's Renal Division Clinic Help line at 888-736-2543 x 2 (Monday - Friday, 8:00 AM - 5:00 PM CST).
Retiro De Equipo (Recall) de Device Recall SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE
  • Tipo de evento
    Recall
  • ID del evento
    64718
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1367-2013
  • Fecha de inicio del evento
    2013-03-13
  • Fecha de publicación del evento
    2013-05-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-12-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117450
  • 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
    Cytocentrifuge - Product Code IFB
  • Causa
    Separation technology, inc. recalled slideprep plus cytology centrifuges manufactured prior to january 1, 2013 for having the potential to start up unexpectedly when encountering an electrostatic discharge.
  • Acción
    On March 13, 2013, Separation Technology, Inc. sent their customers letters instructing them to complete and return the attached Acknowledgement & Receipt form via fax to (407) 788-3677 and requesting the return of the SlidePrep Plus Cytology Centrifuges to STI for correction. For any questions regarding this recall, call STI Customer Service at (800) 777-6668.
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