Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: varian truebeam and truebeam stx versions 1.0 through 1.5
medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning truebeam and truebeam stx versions 1.0 through 1.5
the manufacturer reported that an anomaly that has been identified with the respiratory gating software of truebeam. when importing breath-hold gating protocols, the gating thresholds can be reset to default values; rather than retaining the thresholds established during planning
when using the respiratory gating functionality of truebeam and truebeam stx, it is necessary to import the gating protocol during the first treatment session. an anomaly has been observed when importing gating protocols that have been designated as "breath-hold" during ct simulation. the anomaly causes the "breath-hold" setting to be ignored upon import of the gating protocol. this by itself does not lead to changes in the gating thresholds, but the respiratory gating software has been designed to discard the imported gating thresholds when the gating technique (i.E., breath-hold, amplitude, or phase) is changed from one setting to another. thus, the gating thresholds for "breath-hold" gating are discarded when the operator realizes that the parameters of the imported gating protocol are not correct and they select the "breath-hold" option.
it is also possible for the default gating thresholds to replace the planned thresholds if operators navigate forward and backward through the steps in the gating import wizard. at one step in the process, the default gating thresholds will be selected if the gating technique has been changed. there is no indication that the default settings are being selected by the selection during the gating import process. once the replacement has occurred, the only way to recover the plan gating thresholds is to cancel the import process and start again.
according to the local supplier, the affected devices were distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.
posted on 18 may 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: 4d integrated treatment console (4ditc), version 8.1 sp2 to 10.1 sp1
medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning 4d integrated treatment console (4ditc), version 8.1 sp2 to 10.1 sp1.
4d itc is designed to assist in providing radiation treatment for patients. there are circumstances in which the 4ditc may be involved in a failure to correctly record treatment history information. the majority of the issues experienced fall into one of three general categories:
communication issues between the clinac sub-systems and the 4ditc.
communication issues between the 4ditc and the oncology information system (ois).
unplanned shut down of the 4ditc or the clinac during treatment.
according to the manufacturer, the root cause is related to software design deficiency. varian has scheduled for a mandatory upgrade of the 4ditc to version 10.2 in order to address the above issues.
varian also supplemented that the device has been distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Urgent field safety notice: eclipse 10 (client builds 10.0.28 and 10.0.34)
medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning eclipse 10 (client builds 10.0.28 and 10.0.34).
the issue is that the treatment field energy may change from the current selection to a previous selection without user intervention and without invalidating the mu (monitoring unit) or calculated dose distribution. the energy shown or selected by the treatment planner in the fields tab of external beam planning and in the general tab of field properties may differ from the value actually used for dose calculation.
this issue is caused by incorrect handling of the energy mode object within the memory cache system used by eclipse external beam planning version 10. varian recommends the users to observe the followings:
do not use multiple sessions in eclipse;
always close the patient file in eclipse after completing work on the patient record;
always close eclipse fully before opening a new patient.
furthermore, users should compare the energy shown in dose section and lmc section (if applicable) of the “errors and warnings from last calculation” log in the calculation tab of the field properties dialog with the energy value shown in the fields tab of external beam planning to detect a discrepancy; and confirm and verify all treatment planning calculations.
varian is notifying potentially affected customers and preparing a correction for eclipse version 10 to address this issue.
according to the supplier, hk is not affected by this field safety notice.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Urgent field safety notice: clinac®, trilogy®, trilogy tx™ and novalis tx™ accelerators
medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning clinac®, trilogy®, trilogy tx™ and novalis tx™ accelerators, due to the potential for gantry collisions during remote motion, which may result in patient injury.
varian is sending a notification letter to remind users of varian products to take adequate precautions and exercise due care in all aspects of gantry motions, particularly remote motions. failure to follow the instructions in varian’s user documentation, warnings and other product labeling may increase the risk of a collision between the accelerator gantry and the patient, couch, or nearby equipment or personnel.
according to the supplier, the affected devices have been distributed hk. if you are in possession of the affected product, please contact your supplier in case of doubt.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Urgent field safety notice: eclipse™ electron monte carlo (emc) release 6.5 thru 8.9 (dcs build 7.5.Xx thru 8.0.Xx and dcf build 8.1.Xx thru 8.9.17), and eclipse release 10.0 (dcf build 10.0.25 and 10.0.28)
medical device manufacturer, varian medical systems, issued an urgent field safety notice concerning eclipse emc release 6.5 thru 8.9 and eclipse release 10.0, due to the configuration of the eclipse emc algorithm with non-equidistant data points in the open air profile may lead to inaccurate results, which may result in incorrect dose in the lateral direction.
varian is sending a notification letter to remind users of the necessary actions.
according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for the corrective actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: varian fastplan treatment planning system
medical device manufacturer, varian medical systems (varian), has issued a field safety notice concerning fastplan treatment planning system.
according to varian, an anomaly has been identified with the ct localization module of the fastplan treatment planning system. if the module reports a significant difference in tilt or spin on a slice (compared to the average of all slices) and the user elects to “discard” that slice, an incorrect calculation of the isocenter location may result. if this issue goes undetected, the reported coordinates of the isocenter will be incorrect and a mistreatment could result.
varian is notifying all possibly affected customers with a field safety notice.
according to varian, the affected devices were distributed to hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: varian eclipse™ treatment planning system
medical device manufacturer, varian medical systems (varian), has issued a field safety notice concerning eclipse™ treatment planning system, versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0.
according to varian, an anomaly has been identified with the eclipse™ treatment planning system where the calculated dose distribution is not updated or invalidated when a recalculation or reload is performed while the compensator or fluence editor is open. the issue may go unnoticed. proceeding to approve and treat with such a plan can result in the delivered dose distribution not matching the calculated dose distribution.
varian is notifying all possibly affected customers with a field safety notice. according to varian, the affected devices were distributed to hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: 4d integrated treatment console (4ditc) v8.6 or 8.8 in combination with treatment planning systems
medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning 4d integrated treatment console (4ditc) v 8.6 or 8.8 in combination with treatment planning systems.
it has been identified that in certain configurations, the 4ditc can interpret a rapidarctm or vmat treatment field as 3d conformal arc treatment plan. if it happens, the field will be delivered with a constant dose rate and gantry speed for the entire duration of the delivery, which can lead to delivered dose being different from the planned dose.
according to varian, this will only happen when the change in mu/deg between consecutive control points is small. in other words, it can only happen when the dose rate or gantry speed vary in a very smooth and progressive way for the entire rapidarc field. rapidarctm treatment plans created with eclipse 8.2 and higher or potentially vmat treatment plans created with 3rd party treatment planning systems, when delivered on the 4ditc v8.6 and v8.8 can be incorrectly identified as 3d conformal arc treatment plan.
varian is now notifying all affected customers and will update the 4ditc software to address issues related to proper recording of treatment information from varian machines.
according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: 4d integrated treatment console (4ditc) versions 8.1.3 to 8.8
medical device manufacturer, varian medical systems, has issued an urgent field safety notice concerning 4d integrated treatment console (4ditc) v8.1.3 to 8.8.
varian has identified that after a plan with wedge field has been opened in 4d integrated treatment console, users may not notice that the wedge filter may actually be missing from a selected field, and the treatment application will not notify the user of this anomaly and will not prevent beam delivery. the user may come to understand that the wedge filter is missing only after the treatment field has been partially or completely delivered and when the user attempts to close the patient from the treatment application. with this situation the treatment application forces the user to unload the patient, requires user authorization, and informs the user that the treatment record for the missing wedge field will not be saved to the ois.
varian supplemented that delivery of a treatment field without the planned and calculated wedge filter could result in an over dosage for that beam and potentially an unintended dose uniformity of the target treatment volume.
varian is now notifying all affected customers and providing instructions regarding the use of wedges and secondary channel integrity check (scic) which is a data integrity check to further ensure safety of the radiation beam delivery. in addition, varian will provide a software upgrade to all affected users to correct the problems mentioned above.
according to the local supplier, the affected devices have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: varian clinac, trilogy, novalis tx and unique jaw carriers
medical device manufacturer, varian medical systems, has issued a field safety notice concerning clinac, trilogy, novalis tx and unique jaw carriers.
according to varian, an anomaly has been identified with the clinac, trilogy, novalis tx and unique jaw carriers. the jaw carriers function to couple the x-jaws to their respective drive screw mechanisms used for controlling field size. some jaw carriers were manufactured with the incorrect metal alloy, which can potentially cause the jaw carrier to crack.
if both jaw carriers on the same x-jaw were to crack, the jaw would be able to move freely in the closed direction. in this case, the deviation of the jaw position will not be detected by the position readout interlock circuitry. treatment after such a failure occurs may lead to an underdose of the intended target volume. this condition was found on some machines. no patient mistreatments were reported to varian medical systems.
according to the local supplier, the affected devices have been distributed in hong kong.
if you are in possession of the products, please contact your supplier for necessary actions.
posted on 20 august 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: eclipse treatment planning systems [versions 8.9 & 10.0]
medical device manufacturer, varian medical systems, has issued a medical device safety alert concerning eclipse treatment planning systems [versions 8.9 and 10.0].
according to the manufacturer, an anomaly that has been identified with the eclipse treatment planning system where an outdated assigned hounsfield unit [hu] value can be used for dose calculation when the clock on the eclipse client workstation is not synchronized with the database/system server.
when the eclipse client workstation clock is running behind the clock on the database/system server, it is possible that a change to the assigned hu value for a structure does not invalidate the density image stored in the cache, and for the subsequent dose and monitor unit [mu] calculation to be based on the outdated hu assignment. the resultant mus may be higher or lower than expected, dependent on the specific hu assignments. treatment of the patient using these values can therefore lead to under- or over-dose.
for this situation to arise, the eclipse workstation client clock must show an earlier time than that on the database/system server clock (for example, client time shows 09:05:17, server time shows 09:13:47). the following activities must take place on that client workstation for the discrepancy to occur:
an hu value must be assigned to one or more structures.
the plan must be saved. this places a timestamp (s) on the dcf cache files, where s is the current server time.
the dose is then calculated.
the dose is cleared (for example by resetting the calculation area).
then either a new hu value is assigned to a structure, or an existing hu value is modified.
before the current client time reaches the time the server showed at s, the plan must be recalculated. the calculation will then be based on the outdated hu value that existed at time s.
an independent verification of the mus will highlight the discrepancy.
the manufacturer advises all users to ensure that the workstation clock is synchronized with the database/system server clock.
according to the manufacturer, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 31 august 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: varian eclipse treatment planning system and aria
medical device manufacturer, varian medical systems has issued a medical device safety alert concerning eclipse treatment planning system, aria for radiation oncology, aria radiation therapy management, and acuity. the affected software versions are 11 and 13.
an anomaly has been identified with the plan parameters workspace within eclipse treatment planning system, aria radiation oncology, aria radiation therapy management, and acuity. when a dose relevant parameter is changed and “do not clear monitor units and reference point dose” is selected, the monitor units may change.
the monitor units of the plan may change without the user being aware when all of the following conditions are fulfilled:
the plan has a primary reference point with geometrical location and
the dose prescription percentage at the primary reference point is not 100% and
3d dose distribution is cleared and
“do not clear monitor units and reference point doses” has been selected in the “clear 3d dose dialog” box and
any dose relevant parameter is changed in the plan parameters workspace.
when all these conditions are fulfilled, the dose is rescaled such that the 100% isodose is shifted to the primary reference point location. consequently, the monitor units for each treatment field will change and will not meet the dose prescription intended.
for example, if the dose prescription percentage was 85% in the original plan, and a dose relevant parameter is changed, the dose prescription percentage will rescale to 100%. the monitor units will be correspondingly increased. thus, the plan will no longer meet the intended dose prescription.
also, the manufacturer recommends a thorough review of treated patient plans for plans with a primary reference point with geometric location and where modifications were made in the plan parameter workspace.
the manufacturer is developing a technical correction for the issue.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 9 december 2013.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: varian medical systems on-board imager
medical device manufacturer, varian medical systems, has issued a medical device safety alert concerning its on-board imager.
the manufacturer has received three reports that the shaft of the type 01 elbow motor for exact arms used in the on-board imager [obi] device have failed due to belt over-tensioning. this over-tensioning would have taken place during servicing. this failure would allow the exact arm to swing freely with gravity. no injuries have been reported to-date. only type 01 elbow motors are subject to these potential failures.
according to the manufacturer, potential injury from the kv source striking a patient is dependent upon the anatomic site being treated and the height of the couch. the risk is greatest when the obi x-ray source is extended or retracted while it is above the patient. a geometric analysis determined that when the couch is positioned for a pelvis treatment [e.G., prostate treatments], the head of the patient could be positioned within the arc travelled by the kv source. if the kv source were to strike the patient’s head or chin, a fracture injury is possible. pelvic treatments with couch vertical positions less than 10 centimeters below isocenter have the highest potential for injury.
the manufacturer instructs all affected users not to extend or retract the kv source arm when it is above a patient until the manufacturer inspects the obi exact arms. users should ensure that the gantry is positioned so that the kv source is lateral to, or underneath, the patient-couch prior to extending or retracting the arm.
according to the manufacturer, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 26 march 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: varian medical systems c-series high energy linear accelerator
medical device manufacturer, varian medical systems, has issued a medical device safety alert concerning its c-series high energy linear accelerator, [affected models: novalis tx, trilogy, trilogy tx, clinac ix, clinac cx, clinac 2100 c/d, clinac 2300 c/d, clinac dx, clinac 21 ex, clinac 23 ex 6 mv configurations only].
the manufacturer has seen a trend in reports of unexpected decrease in beam output in c-series high energy linear accelerators for 6mv photon treatment mode. this failure mode in the target only affects the 6 mv photon treatment modes (6srs, 6fff, and 6x). no other energies are affected.
the manufacturer has determined the cause of the unexpected variations in beam output to be degradation of the 6mv target. specifically, the effects of modern, highly modulated treatment modes can create high levels and frequency of stress cycles in the targets particularly if the beam spot size is small. this can lead to the target’s deterioration and failure at an accelerated rate resulting in a rapid change in the beam output and symmetry. specifically:-
the photon generation, or bremsstrahlung yield, decreases as fewer electrons are converted to photons in the target, and;
due to a resulting escape of primary electrons the output of photons, as measured by the ion chamber, might appear to be constant, but the actual photon output is decreasing
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 24 jun 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: varian aria for radiation oncology, aria oncology information system for radiation oncology
medical device manufacturer, varian medical systems, has issued a medical device safety alert concerning its aria for radiation oncology, aria oncology information system for radiation oncology [versions 10.X, 11.X, 13.0 or 13.5 with clinical assessment license only].
the manufacturer has identified an anomaly with the aria for radiation oncology software with a clinical assessment license. admin instructions may not print on drug order prescriptions or be transmitted with e-rx. when the user changes the prescription “type” field after inputting admin instructions in the text box, the admin instructions portion of the prescription will not be saved to the database. an e-rx transmitted to the pharmacy will not contain the intended admin instructions. the printed prescription will also not contain the intended admin instructions. hence, the pharmacy will not receive the administration information intended by the physician. the manufacturer has not received any reports of patient injury due to this issue.
the manufacturer has provided instructions to affected users and is developing a technical correction for this issue.
according to the local supplier, the affected products are distributed in hong kong
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 7 october 2015.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: varian eclipse treatment planning system: eclipse release 6.5 through 10 (versions 7.3.10 to 10.0.34), model: h48
it has come to our attention that varian medical systems, inc. has issued a global field safety notice to customers regarding the captioned planning system used in radiotherapy treatments. according to the manufacturer, hong kong is affected.
in affected eclipse versions, user editing of mlc leaf positions may not automatically invalidate calculated dose distributions. varian is preparing a maintenance release (service pack) of eclipse software to address the problem.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Field safety notice: varian optical guidance platform (ogp) with frameless array module hz1/hz6
it comes to our attention that an issue has been identified with the varian optical guidance platform (ogp), v 2.6 and 2.6.1 of a possible infrared light reflection resulting in an inability to calibrate the ogp or track the optical guidance tool (accessory) during use. as a result, the ogp may be unable to track the positioning tool or in one reported case, display an improper correction vector.
the risk associated with this error is the offset at isocentre of the beam by 2 mm, which can result in severe injury, death or permanent total disability.
if you are in possession of the affected product, please contact your supplier for necessary actions.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: varian 4d integrated treatment console v10.2.3 and bar-code conical collimator v1.0
medical device manufacturer, varian medical systems has issued a medical device safety alert concerning 4d integrated treatment console (4ditc) v10.2.3 and bar-code conical collimator (bccv) v1.0.
the plan label is not updated correctly in bccv display if multiple plans are open in 4ditc simultaneously. the bccv display always displays the plan label of the first plan. this situation arises only when multiple conical collimator plans are scheduled to be treated in single session.
based on the bccv display, it could be possible that the user may choose a wrong plan from a positioning system that is not interfaced with the 4ditc. if the error of selecting the unintended isocenter in the positioning system went unnoticed, treatment to the incorrect isocenter, with the mu’s and conical collimator size intended for another isocenter could cause a severe under dose or over dose. serious injury or death could occur when a hypo-fractionated radiosurgery field is to be delivered. however, the manufacturer has not received any reports of misadministration.
the manufacturer advised the affected users to take the following recommended actions:
do not use bccv as a primary reference for identifying the correct plan to be treated. the user should always refer to the 4ditc for identification of the plan and field that has been moded up for treatment. care must be taken at all times in selection of the isocenter in the positioning system. the printed information sheet from the treatment planning system should match the patient name and plan name on the 4ditc before selection of the isocenter in the positioning system. it is imperative that a secondary check of the patient id, plan name and isocenter selection be made before treatment commences.
caution should be used when selecting an isocenter in a positioning system that is not interfaced to the 4ditc.
any discrepancies in planned versus actual parameters should be brought to the attention of the medical physicist for investigation before treatment begins.
one workaround is to schedule one plan per session.
the solution of the problem consists of a software upgrade to the bccv from v1.0 to v2.0.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 22 november 2012.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: varian rpm respiratory gating system
medical device manufacturer, varian medical systems has issued a medical device safety alert concerning real-time position management (rpm) respiratory gating systemv1.7.5 with 3d option.
an anomaly has been identified with the rpm respiratory gating system software version 1.7.5, 3d option. while operating with the 6-dot marker block, this version of rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions.
trace inversion occurs when the breathing trace on the chart window moves in a phase opposite to the marker block movement. this event has been reported in an extremely limited number of times in the installed base, but users should be aware and monitor their displays carefully.
the error may be reproduced if the rpm system is induced to frequently lose and re-acquire tracking of the 6-dot marker block during a calibration sequence, a reference session, or a single session after tracking has begun. in practice, this has been extremely rare.
the root cause of the malfunction has been determined to lie within the smarttrack software library used only by rpm v1.7.5 with the 3d option. therefore, the manufacturer has developed a technical correction for this issue.
according to the local supplier, the affected products were distributed in hong kong.
if you are in possession of the affected product, please contact your supplier for necessary actions.
posted on 8 april 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: ventlab resuscitator bags
the united states food and drug administration (fda) has issued a medical device safety alert concerning ventlab resuscitator bags, manufactured from ventlab, llc.
the manufacturer has initiated a voluntary medical device removal of a limited number of ventlab resuscitator bags after becoming aware of complaints regarding a sticking duckbill valve that resulted in the resuscitation bags delivering no air through the patient valve, to the patient. the valves may stick due to incomplete curing during the manufacturing process. resuscitation bags affected may not function properly and may result in a delay of treatment and life threatening health consequences that include hypoxia and hypoventilation.
there has been one report of injury requiring medical intervention due to the lack of a functional resuscitation bag and 31 reports of a delay in oxygenation due to the requirement to utilize a 2nd or 3rd device.
the manufacturer advises users to stop using the affected products and return these products to the manufacturer.
for details, please refer to the fda websites:
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm397749.Htm
http://www.Fda.Gov/safety/recalls/ucm397682.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 19 may 2014.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: king systems universal flex2 breathing circuit
the united states food and drug administration (fda) has issued a medical device safety alert concerning universal flex2 breathing circuit [part no.: df4110-61; lot no.: i063n], manufactured by king systems corporation.
the manufacturer received a customer complaint indicating that the customer had ordered a breathing circuit with a latex breathing bag. the product they received contained a latex breathing bag, but was labeled as non-latex.
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-2272-2013&w=10092013&lang=eng
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 24 october 2013.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
Notas adicionales en la data
Medical Device Safety Alert
Causa
Medical device safety alert: vyaire medical air life humidification chamber & heated breathing circuit kits
the united states food and drug administration (fda) is issuing a medical device safety alert regarding the
air life humidification chamber & heated breathing circuit kits, manufactured by vyaire medical. the affected devices are identified as the following: -
air life humidification chamber & heated breathing circuit kits
lot codes: ah290, ah132, ah265, ah202, and ah280
manufacturing dates: 18 may 2017 to 28 september 2017
distribution dates: 3 july 2017 to 10 november 2017
according to the fda, the manufacturer is recalling the airlife humidification chamber and heated breathing circuit kits due to a manufacturing error that may cause parts of the chamber to split apart into layers, allowing water to overflow the chamber and to back up into the patient breathing circuit. if this occurs, an excessive amount of water could enter the airway or lungs of a ventilated patient and lead to serious adverse health consequences, including injury or death.
the manufacturer sent an urgent recall notification letter instructing affected users to:
inspect inventory on-hand and remove affected lots of the airlife humidification chamber and heated breathing circuit kits
destroy all affected product(s) in-stock in accordance with their facility's destruction protocol
for details, please refer to the fda website:
https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm594566.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 31 january 2018.