Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer states that the coordinate system to be aligned with the adapter frame of the previous systems may experience a movement of the lens up to 0.5mm from the intended position, since the block flanges may cause the frame to be poorly closed preventing the coordinate frame from it is fixed properly, causing a small mechanical mismatch between the decoded system and the frame adapter in the z direction, which can lead to possible adverse events on the patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer has determined that when the user establishes a maximum field size for each filter, this is not stipulated by the software when the fixed filters and mlc are present in the column, therefore the calculation is incorrect and the administration of the dose is out of the physical area of the filter, resulting in that the dose of distribution calculated by the software does not coincide with the dose administered, which could lead to the potential occurrence of adverse events on the patient.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer has detected that the frame adapter latches can be locked if the locating pins are not inserted into the corresponding holes in the decoded frame, which could lead to potential delays in patient care or adverse events on patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer has determined that in a specific workflow in which the contours are modified (expanded, moved, copied, etc.) and then the contour of some cuts is deleted and saved in the same session, it is it is possible that the deleted contours are still present, even though the planner would like to eliminate them, which could lead to the potential occurrence of adverse events on the patient due to administration of incorrect doses and treatments.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer reports that if the tc data contains cuts that occur at the xx, x50 mm positions, there may be parts of the volume where there is a mismatch between the contour graphs on the screen and the contour data used during the optimization and the calculation of the dose, which could lead to potentially adverse events on the patient due to dose administration and incorrect treatments.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer has determined that the system of gears and the drive wheel of the base of the support could be loosened by the fastening bolts, which could lead to potentially adverse events occurring on the patient or user.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer has determined that when creating 3d plans using the um weight or dose modes, if the user modifies the treatment dose and / or the number of fractions of the physician's intention, and then changes the angle of the wedge, the value of um is not scaled correctly, the um scale is directly proportional to the change of the fraction, if the monitor units are not correct, in the treatment of the patient there may be an overdose or critical infrequency proportional to the redefinition of the fractions, which could lead to present potentially adverse events on the patient.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer has determined that when a plan3d of monaco is exported through dicom and the check box "composite field sequencing" (cfs, [field composition sequencing]) is selected, the jaws y are set to the shape of the port, despite that they should continue how and where they were defined. this fact takes place when the shape of the port used to define or edit the positions of the mlc extends beyond or within the actual positions of the jaws, the problem is when a workflow is used for the imrt with direct planning involving the creation of several you do for the same gantry angle with a single mlc shape defined for each beam, these beams then see the cfs to combine the individual 3d beams into a single sequence of imrt beams, leading to an overdosage or receive less than necessary, which could potentially cause the presentation of adverse events on the patient.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer reports that the dose that is calculated from wedge bundles can be assigned to the erroneous beam, this situation can be achieved with a plan that has at least two beams and in which the monitored wedge is used, leading to the potential occurrence of adverse events about the patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer states that the routes of the measured sources of the referenced applicators, with a step size of the source of 2.5mm for the microselectron deferred charging device, constitutes the source of the alert, if this model of applicator is used to create an unplan, although the size of the step of the default source of the deferred loading device is 5.0mm, the size of the ovoid passage in the form of a ring or semicircular will be incorrect, 2.5 m will be indicated, although the deferred loading device will administer a dose at 5.0 mm. the error is detected during the approval of the plan, which may lead to the occurrence of potentially serious adverse events on the patient.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer has identified reports that the depth stop dbs is not fixed correctly to the electrode, the analysis of the returned products indicates that the threaded area of the depth deltope screw was not large enough to allow the electrode to be fixed in the depth stop , so that the electrode slid through the stop, leading to possible adverse events on patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer warns that it has detected the possibility that using the referenced filters the user could be exposed to a diffuse reflection of the laser beam, leading to the presentation of possible adverse events on the users.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer reports that it has detected that the frequency of displacement of the implants, of endoleaks or the size of the aneurysm has been higher than expected, therefore, it has decided to update the instructions of use with more detailed information of the indications of use, selection criteria of the patient and optimal practices for the intervention, avoiding that its misuse leads to the occurrence of potentially adverse events on patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer informs that it will carry out an update and modification of its instructions for use, which should be made known to the medical personnel who use this technology, avoiding that its misuse leads to the occurrence of potentially adverse events on the patients.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
To remove from the market batch no. 16-0647 of the in-vitro diagnostic reagent total protein plus, due to the fact that.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Notas adicionales en la data
Causa
The manufacturer reports that it has identified the possibility of the valve of the device adhering during storage resulting in its occlusion, which will not allow delivery of the gas normally administered through the valve, leading to the occurrence of possible adverse events on the patient and delaying the process.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.