Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Recommendations for users and patients: To manipulate a cardiac ablation catheter, use only the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.
Causa
The company clarifies that "microscopic metal particles may be generated during intracardiac surgery, both robotic and non-robotic. use of other da vinci instruments other than the heart probe hold device (e.G., the large needle driver) to manipulate a cardiac cryoablation probe during da vinci heart surgery has been shown to increase the amount of microscopic metal particles. the purpose of this communication is to inform that only the heart probe hold device should be used to manipulate a cryoablation probe in cardiac procedures. ".
Acción
Risk classification: III /// Field action classification: Update and complementation of the Instructions for use /// Field action code: TECNOVIGI / AC / 02-2016 /// Recommendations to users and patients: To manipulate a probe only use the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Recommendations for users and patients: To manipulate a cardiac ablation catheter, use only the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.
Causa
The company clarifies that "microscopic metal particles may be generated during intracardiac surgery, both robotic and non-robotic. use of other da vinci instruments other than the heart probe hold device (e.G., the large needle driver) to manipulate a cardiac cryoablation probe during da vinci heart surgery has been shown to increase the amount of microscopic metal particles. the purpose of this communication is to inform that only the heart probe hold device should be used to manipulate a cryoablation probe in cardiac procedures. ".
Acción
Risk classification: III /// Field action classification: Update and complementation of the Instructions for use /// Field action code: TECNOVIGI / AC / 02-2016 /// Recommendations to users and patients: To manipulate a probe only use the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
BARD safety notice regarding the withdrawal and use of ARCTICGEL cooling pads
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Recommendations for users and patients: To manipulate a cardiac ablation catheter, use only the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.
Causa
The company clarifies that "microscopic metal particles may be generated during intracardiac surgery, both robotic and non-robotic. use of other da vinci instruments other than the heart probe hold device (e.G., the large needle driver) to manipulate a cardiac cryoablation probe during da vinci heart surgery has been shown to increase the amount of microscopic metal particles. the purpose of this communication is to inform that only the heart probe hold device should be used to manipulate a cryoablation probe in cardiac procedures. ".
Acción
Risk classification: III /// Field action classification: Update and complementation of the Instructions for use /// Field action code: TECNOVIGI / AC / 02-2016 /// Recommendations to users and patients: To manipulate a probe only use the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Recommendations for users and patients: To manipulate a cardiac ablation catheter, use only the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.
Causa
The company clarifies that "microscopic metal particles may be generated during intracardiac surgery, both robotic and non-robotic. use of other da vinci instruments other than the heart probe hold device (e.G., the large needle driver) to manipulate a cardiac cryoablation probe during da vinci heart surgery has been shown to increase the amount of microscopic metal particles. the purpose of this communication is to inform that only the heart probe hold device should be used to manipulate a cryoablation probe in cardiac procedures. ".
Acción
Risk classification: III /// Field action classification: Update and complementation of the Instructions for use /// Field action code: TECNOVIGI / AC / 02-2016 /// Recommendations to users and patients: To manipulate a probe only use the Heart Probe Hold Device. Although there is a possibility of metal particle generation in any surgery, it has been shown that the use of other da Vinci instruments (eg the Large Needle Conductor) to manipulate a cardiac ablation probe increases the generation of metal particles.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
This is a situation in which the use of the product is not likely to cause adverse health consequences. Action Required for Laboratories that Own the Affected Lot: • As soon as available, install ADD DRV 5884 or later on your VITROS system. • E-Connected Systems: Automatic download will be available in early May 2016. • ADD DRV 5884 or later will also be shipped to your facility upon availability. NOTE: After loading ADD DRV 5884 or later for the first time, the VITROS dTIBC GEN 30 Reagent will lose the calibration and must be recalibrated. • After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory of the VITROS dTIBC, GEN 30 Reagent. • Place this notification on your VITROS System or along with your user documentation. • Fill out and return the Receipt Confirmation form If you have any questions regarding this field action, please contact Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. by telephone: 12 3932-7977 or e-mail: gbuosi@its.jnj.com
Causa
The manufacturer has detected that there are incorrect values (data / calibration math) on assay data diskettes (add) for calibrator kit 29, which supports the vitros dtibc, gen 30 reagent. incorrect values will cause a positive trend in the sample results (ie, patient samples, proficiency fluids, and quality control fluids).
Acción
Field Action No. 16000095 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Action Required for Laboratories that Own the Affected Lot: • As soon as available, install ADD DRV 5884 or later on your VITROS system. • E-Connected Systems: Automatic download will be available in early May 2016. • ADD DRV 5884 or later will also be shipped to your facility upon availability. NOTE: After loading ADD DRV 5884 or later for the first time, the VITROS dTIBC GEN 30 Reagent will lose the calibration and must be recalibrated. • After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory of the VITROS dTIBC, GEN 30 Reagent. • Place this notification on your VITROS System or along with your user documentation. • Complete and return the Receipt Confirmation form
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The company ADCA will carry out a correction in the field that will consist of: 1 - Verification and separation of products in the clients' inventories; 2 - field correction of the products with the provision and fixation of the external labels and labels of trail with the correct information. The ADCA will send to the health facilities the traceability labels with the correct registration number along with guidelines for corrections to the medical charts and records of the patients. However, ADCA recommends that patients and users who have used the series of products checked, contact ADCA customer service channels at (31) 3496-1855 or by e-mail sac@adca.ind.br, so that they can learn how and when the traceability labels will be made available for field correction.
Causa
Some batches of adca clips whose references are mxt016; mxt058; mxt116; mxt117 and mxt143 had their external labels and trace labels printed with the wrong registration number. the registration number printed on the outer label and on the trace labels was 80116050003, which corresponds to the adca force clip, when the correct registration number to be printed would be 80116050002, corresponding to the adca aneurysm clips.
Acción
Field Action No. 01/2016 triggered under the responsibility of the company ADCA - INDÚSTRIA E COMÉRCIO DE MATERIAL CIRÚRGICO LTDA. The action in the field aims to promote the correction of the labels and labels of trail of the clips according to the correct registration of the product, ADCA will make a correction in the field that will consist of: 1 - Verification and separation of products in the clients' inventories ; 2 - field correction of the products with the provision and fixation of the external labels and labels of trail with the correct information.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The MDT recommends: 1. Locating in the company the aforementioned lots and stocking these lots, performing immediate segregation and sending them to MDT, through a Return Invoice; 2. Locate the batches that have been used in the surgical procedure and inform the implantation data, as requested in the Traceability Monitoring. Recommendations to Users and Patients: If there is any adverse event involving the products mentioned in the Collection Action (which can be verified on the Traceability Labels sent to each product), it should be reported to the Distributor and MDT. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Failure of tolerances between insert and acetábulo, causing micro movements.
Acción
Field Action No. RR112Q- RR017Q- RR085Q- RR087Q triggered under the responsibility of the company MDT Industry Import and Importation Exports Implants. Field Action: Pickup - Return to manufacturer.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Impact on client outcomes: When using Trulab controls: no impact is observed on patient outcomes, as the variation observed in the parameters is considered insignificant. When using the Trucal U calibrator, lot 20695, whose calibration value for AST / GPT changes from 105 U / L to 99.8 U / L, thus occurring a variation of -5%, it will happen that when using this new value of patient outcomes will also be diverted / changed by -5%.
Causa
Biosys ltda, who registered the referenced products, received a report from the international manufacturer of these products, diasys diagnostic systems gmbh, stating that the internal measurements carried out by the quality assurance showed that target values of some parameters of the trulab n, trulab p, trulab protein, trulab urine and trucal u-universal calibrator had to be redesignated following the parameters that were re-assigned by product: a) in trulab n and trulab p: alkaline phosphatase, alt / gpt, total bilirubin, chloride, ck, gldh , glucose, igm and lipase. b) in trulab protein: myoglobin, c-reactive preotein. c) in trulab urine level 2: creatinine. d) in trucal u: ast / got. biosys informs that it has not.
Acción
Classification of risk: II /// Classification of the field action: correction in the field /// Field action code: 2832 /// Recommendations to users and patients: replace the previously reported target values with the new target values reported in Informative letter sent via email. And they are informed that the updated values of target value can also be obtained through the link: http://www.diasys-diagnostics.com/service-area/value-sheets/.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Impact on client outcomes: When using Trulab controls: no impact is observed on patient outcomes, as the variation observed in the parameters is considered insignificant. When using the Trucal U calibrator, lot 20695, whose calibration value for AST / GPT changes from 105 U / L to 99.8 U / L, thus occurring a variation of -5%, it will happen that when using this new value of patient outcomes will also be diverted / changed by -5%.
Causa
Biosys ltda, who registered the referenced products, received a report from the international manufacturer of these products, diasys diagnostic systems gmbh, stating that the internal measurements carried out by the quality assurance showed that target values of some parameters of the trulab n, trulab p, trulab protein, trulab urine and trucal u-universal calibrator had to be redesignated following the parameters that were re-assigned by product: a) in trulab n and trulab p: alkaline phosphatase, alt / gpt, total bilirubin, chloride, ck, gldh , glucose, igm and lipase. b) in trulab protein: myoglobin, c-reactive preotein. c) in trulab urine level 2: creatinine. d) in trucal u: ast / got. biosys informs that it has not.
Acción
Classification of risk: II /// Classification of the field action: correction in the field /// Field action code: 2832 /// Recommendations to users and patients: replace the previously reported target values with the new target values reported in Informative letter sent via email. And they are informed that the updated values of target value can also be obtained through the link: http://www.diasys-diagnostics.com/service-area/value-sheets/.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Impact on client outcomes: When using Trulab controls: no impact is observed on patient outcomes, as the variation observed in the parameters is considered insignificant. When using the Trucal U calibrator, lot 20695, whose calibration value for AST / GPT changes from 105 U / L to 99.8 U / L, thus occurring a variation of -5%, it will happen that when using this new value of patient outcomes will also be diverted / changed by -5%. ### UPDATED ON 09/27/2017, the company sent the company presented information of the field action proving the sending of the safety notice to the client and terminating the field action.
Causa
Biosys ltda, who registered the referenced products, received a report from the international manufacturer of these products, diasys diagnostic systems gmbh, stating that the internal measurements carried out by the quality assurance showed that target values of some parameters of the trulab n, trulab p, trulab protein, trulab urine and trucal u-universal calibrator had to be redesignated following the parameters that were re-assigned by product: a) in trulab n and trulab p: alkaline phosphatase, alt / gpt, total bilirubin, chloride, ck, gldh , glucose, igm and lipase. b) in trulab protein: myoglobin, c-reactive preotein. c) in trulab urine level 2: creatinine. d) in trucal u: ast / got. biosys informs that it has not.
Acción
Classification of risk: II /// Classification of the field action: correction in the field /// Field action code: 2832 /// Recommendations to users and patients: replace the previously reported target values with the new target values reported in Informative letter sent via email. And they are informed that the updated values of target value can also be obtained through the link: http://www.diasys-diagnostics.com/service-area/value-sheets/.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
The recommendations below are intended for physicians / health professionals, and further details of the guidelines can be found in the FA729 Customer Letter: 1) Patient anatomy considerations: Physicians should consider whether complex anatomical configurations, including combinations of two or more traits below, raise the risk of vascular trauma. 2) Procedure Use: During the advancement of the introduction system, enlarge the images sufficiently to allow the tip of the capsule to be viewed relative to the vasculature of the patient. If you observe the tip of the infeed folding system in a different direction from the infeed cap, do not force the infeed. Instead, retract the introduction system to a straight part of the descending aorta, reorient it by rotating the 90 degree introductory system and restart the passage very carefully. 3) Use of the procedure: If significant resistance is encountered during the advance of the introduction system, do not force the passage. Use magnification of fluoroscopy to evaluate the vasculature. If no damage is identified, retract the delivery system to a straight portion of the descending aorta and consider the actions outlined in the FA729 Customer Letter. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Possible vascular trauma using medtronic's enveo ™ r catheter entry system (dcs). although reports of vascular trauma received by medtronic were not frequent (0.136%, 39 events), they contained serious results, including death of patients (19 events). the field action, as described in the enclosed customer letter fa729, encompasses two distinct models of the core valve evolut r aortic transcatheter valve, these models are: 1. enveor-l; and 2.Enveor-lc. however in brazil, medtronic holds the registration and commercializes the model enveor-l (registration no.: 10339190629).
Acción
Field Action No. FA729 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. The Field Action is an update of the instructions for use. Recommendations for Physicians / Health Practitioners: 1) Patient Anatomy Considerations: Physicians should consider whether complex anatomical configurations, including combinations of two or more traits below, increase the risk of vascular trauma. 2) Procedure Use: During the advancement of the introduction system, enlarge the images sufficiently to allow the tip of the capsule to be viewed relative to the vasculature of the patient. If you observe the tip of the infeed folding system in a different direction from the infeed cap, do not force the infeed. Instead, retract the introduction system to a straight part of the descending aorta, reorient it by rotating the 90 degree introductory system and restart the passage very carefully. 3) Use of the procedure: If significant resistance is encountered during the advance of the introduction system, do not force the passage. Use magnification of fluoroscopy to evaluate the vasculature. If no damage is identified, retract the delivery system to a straight portion of the descending aorta and consider the actions outlined in the FA729 Customer Letter.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Cordis safety note on SUPER TORQUE MB angiographic catheters
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Recommendation to users and patients: - do not use 6C1 HD and 18L6 HD transducers with CIVCO biopsy connectors for guided biopsy procedures. - do not reposition the region of interest of the Virtual Touch IQ from the original location (default). SEE TECNOVIGILANCE ALERTS: 1649; 1673 If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AEs) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Siemens healthcare diagnósticos sa informs that the field action us006 / 16 / s consists of the software update. when using the equipment with the outdated software it is possible that: - when using the civco biopsy connectors in combination with the acuson s family screen orientations. the path of the biopsy needle may not match the orientation of the screen. this occurs on 6c1 hd and 18l6 hd transducers (alert 1673). - when repositioning the region of interest of the virtual touch iq from its original location (default), the lateral position of the measuring tool (indicated in yellow) may not be in line with the lateral position of the shear rate data (alert 1649).
Acción
Field Action No. US006 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA The Field Action deals with field correction, software update, upon previous sending of letter to the client. Recommendation to users and patients: - do not use 6C1 HD and 18L6 HD transducers with CIVCO biopsy connectors for guided biopsy procedures. - do not reposition the region of interest of the Virtual Touch IQ from the original location (default).
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
#### UPDATED ON 08/23/2017, the company submitted completion report of the field action proving the action of reinforcing the instructions for use of the product.
Causa
This letter reports recent results from the review of the returned product, medtronic neuromodulation pocket dynamic adapter (dbs) with high impedance reporting, and reinforces specific device labeling for pocket adaptor manipulation and integrity during implant procedures. this applies to the pocket adaptor models 64001 and 64002 that can be used with the following implantable neurostimulators: activa® pc (model 37601) and activa® rc (model 37612).
Acción
Field Action FA724 Recommendations for Users and Patients: The current labeling for system manipulation during implantation is described in the implant manuals. To minimize the possibility of a connector wire breakage, follow the instructions in the DBS Pocket Adapter System Implant Manual as described below to ensure that the adapter wire is not bent severely or bent at the time of implantation. The complete implant manual can be found on the product packaging. Implanting the Pocket Adapter with the Neurostimulator: 1. Place the Pocket Adapter behind the neurostimulator. Wrap the adapter wire and excess extender wire behind the adapter, making sure the wires do not bend too tightly. Also, perform a thorough inspection of the integrity of the system by checking proper electrode impedances before closing the as described in the Activa® PC Model 37601 Implant Manual.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Recommendation for users and patients: For the first problem the company recommends that the trackball be assigned to the colored region of interest, to the sample or pulsed or continuous wave Doppler courses, to the M mode courses, to the 2D field of view or to the region RES, especially when the temperature of the transducer reaches 40 ° C. If the problem persists, it is recommended to temporarily increase or decrease the transmission energy or wait for the temperature of the transducer to reach 41 ° C. For the second problem described, the company recommends correcting the case / patient differences in the patient's name at the time of registration. SEE TECNOVIGILANCE ALERTS: 1690; 1933 If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
Causa
Siemens healthcare diagnósticos sa informs that the field action us014 / 16 / s consists of the software update. when using the equipment with outdated software, it is possible that - when acquiring an image with a transesophageal transducer (tee) (z6ms, v5ms or v7m), you may lose the ability to control the colored region of interest, the sample or the pulsed or continuous wave doppler courses, the m mode courses, the 2d field of view, or the res region of interest with the trackball. in addition, the acuson sc2000 device considers case / upper case differences in the same patient name as unique occurrences of patients when registered on the same ultrasound system. the system recovers the sensitivity of uppercase and lowercase letters even though the original study has been removed from the hard disk. when these differences are not corrected at registration, the system will not capture images or clips.
Acción
Field Action No. US014 / 16 / S triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA The Field Action deals with field correction, software update, upon previous sending of letter to the client.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Causa
Company stryker reports that it has been identified that there is a potential risk that one or more rivets may come loose from the femoral end mill. displacement of the rivet can cause surgical delay and if the rivet has moved and remained inside the patient, it can generate an inflammatory response in the patient and generate the need for revision surgery.
Acción
Field Action FA724 Pickup: The product must be returned to the manufacturer.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notas adicionales en la data
Causa
Company stryker reports that it has been identified that there is a potential risk that one or more rivets may come loose from the femoral end mill. displacement of the rivet can cause surgical delay and if the rivet has moved and remained inside the patient, it can generate an inflammatory response in the patient and generate the need for revision surgery.
Acción
Field Action FA724 Pickup: The product must be returned to the manufacturer.
Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Poland.
Notas adicionales en la data
Acción
Security note from Alere San Diego Inc. concerning the withdrawal and use of the Triage BNP calibrator (Cat. No. 98202) lot 328163 (K328163)