Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
It has been identified that 16 medtronic neuromodulation dbs system pocket adaptors (0.08% reported rate of occurrence) have been identified with high impedance, resulting in decreased current being conducted through the device. some of the reported cases involved loss of therapy, return of symptoms, rebound effects and potential revision surgery to replace the device. there have been no incidents reported in australia. analysis of the returned devices found the cause of the high impedance to be conductor wire fractures near where the wire exits the neurostimulator connector block. in two cases, the issue was identified during implantation surgery, while the other 14 were identified after implantation and resulted in revision surgery.
Acción
Medtronic is reminding users of the device labelling specific to the handling of pocket adaptors and system integrity checking during implant procedures. This action has been closed-out on 03/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Prodisc-c vivo implants are packaged sterile in a double barrier setup, with an outer foil package and an inner blister package. for the impacted lot, the tyvek lid may be missing from the inner blister package. manufacturer’s assessment has identified that due to the double barrier sterile packaging, the sterility of the implants will continue to be maintained when the tyvek lid is missing. the packaging non-conformance has the potential to result in intraoperative surgical delay. when the outer foil pouch package is opened, the implant may dislodge from the uncovered blister package and has the potential to fall outside of the sterile field.
Acción
Users are advised to inspect stock and quarantine any remaining product for return to Johnson and Johnson. Patients who are implanted with the affected stock should be monitored in accordance with standard practice for the Prodisc-C Vivo treatment process.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The manufacturer has identified that the affected lot of aquasil easy mix putty may exhibit setting characteristics which are not normal for this product. the affected products may exhibit an extended set time. there is no risk to patients.
Acción
Dentsply is advising users to return any remaining unaffected stock. This action has been closed-out on 02/03/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Rex bionics has been made aware of a patient injury, relating to incorrectly securing the heel stops on the rex. the patient suffered bilateral upper and lower tibial and bilateral lower fibular fractures following a spasm which resulted in unsecured heel stops moving backwards. the injuries may have been exacerbated by the use of ankle foot orthoses (afo) which restricted the users’s range of motion greater than required by rex.The heel stop must be correctly aligned with the measurement on the footplate corresponding to the user’s ankle to hind-foot measurement. once adjusted, the heel stop must be secured by tightening the locking nut. failure to do this may cause the user’s leg to move out of alignment, which may result in serious injury.
Acción
Rex Bionics is advising users of the importance of the correct heel stop adjustment, and securing using the tightening of the locking nut. Revised Instructions for Use (IFU) will be provided regarding the heel stops and the use of Ankle Foot Orthoses which limit the range of motion for a patient. This action has been closed out on 16 June 2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Ortho is providing additional information for a product correction notification that was issued in december 2015 (rc-2016-rn-00017-1) regarding the clarification of operator actions for wash errors. since that time, ortho has been monitoring the occurrence of u90-382 or 6lu condition codes associated with wash errors and observed that wash errors were occurring at a higher than expected rate for vitros phyt slides. it was determined that vitros systems could sometimes identify false wash errors. if a u90-382 or 6lu code is generated, the vitros system suppresses the result and “no result” is reported (and review of previously reported results is not necessary).Ortho has identified an improvement to the wash algorithm that will help reduce false wash errors while not compromising the detection of true wash errors. this improvement involves a change to the magenta wash tolerance (mwt) limit and will be implemented on calibration diskette/assay data diskettte (add) drv 5910 and above.
Acción
Ortho is advising users to install Calibration Diskette or ADD DRV 5910 or above on their VITROS system. An automatic download will be available for e-Connected systems as of December 2, 2016. The Calibration Diskette and/or ADD will also be sent to the customer's facility when available. After loading DRV 5910 (or above) for the first time, VITROS PHYT Slides will un-calibrate and will require recalibration. In the interim, the product can continue to be used.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
It has been identified that the initial design of the angle adjustment mechanism for the stander allowed the user to lock out the safety pull pin on the frame and adjust the angle of the stander using one hand. if the operator’s hand slipped off the turning handle when a patient was in the frame then the handle could “self-wind” and spin rapidly as the stander returns to the upright position. whilst there is no risk to the patient in the frame, the fast spinning handle does pose a risk of injury to the operator if they try to take hold of the handle.These issues only impact devices manufactured between january 2012 and august 2013 as the design of the pull pin safety mechanism was changed in august 2013. it is no longer possible to lock the pull pin out and two hands are now required to adjust the stander angle.
Acción
Otto Bock is arranging for distributors to contact users of the affected devices and arrange for replacement of the pull-pin on the device with one that cannot be locked by the operator. The replacement safety pull pin will require the user to hold the pull pin with one hand while turning the adjustment handle with the other hand. If their hand slips off the turning handle, they can simply release the pull pin and the handle will stop winding. For more information, please see https://www.tga.gov.au/alert/james-leckey-design-mygo-stander .
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
A defect has been detected by the manufacturer, which is that the needle detaches very easily during surgery, resulting in the suture having to be replaced and the wound sutured a second time.
Acción
B Braun is advising users to inspect stocks and quarantine all units. B Braun will arrange for stock to be recovered and will issue a credit note.
This action has been closed-out on 28/02/2018.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
The manufacturer, greatbatch medical identified through laboratory testing that the required sterility assurance level (sal) of 10-6 is not achieved on torque limiting adapter when subjected to steam sterilisation cycles identified in the instructions for use (ifu) provided with the device. torque limiting adapter is supplied non-sterile and requires cleaning and steam sterilisation prior to use and subsequent re-use.
Acción
Zimmer Biomet is advising users to immediately locate and remove the identified device. Zimmer Biomet will remove the affected product from the facility.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Beckman coulter has identified that the quality control (qc) value card includes incorrect standard deviation values for the access amh qc kit, lot 689202. the qc value card for this lot lists the following standard deviation values: qc1 as 0.02, qc2 as 0.11 and qc3 as 0.65. the correct standard deviation values are as follows: qc1 is 0.15, qc2 is 0.76 and qc3 is 2.30. use of this restrictive qc range may result in qc failures but there is no impact to patient results.
Acción
Beckman Coulter is advising users to use the correct QC values, as provided, when establishing QC ranges for the affected lot. Users should also confirm that the Access AMH QC assigned mean and standard deviation values are set appropriately per individual laboratory procedures. This action has been closed-out on 20/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Smith & nephew have identified a packaging issue through internal testing. the twinfix quick-t knot pusher suture cutter could be subject to breaches of its sterile packaging. in the event the device is presented for use and a breach in the sterile barrier is not noticed, a non-sterile device could enter the surgical field. smith & nephew has received no customer complaints indicating a packaging breach or a post-operative infection.
Acción
Smith & Nephew is advising users to discontinue use of affected products and quarantine the device(s). The devices are to be returned to Smith & Nephew.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This recall has been initiated because of an error when viewing prior results. a pixel offset issue can occur when prefetching a prior image from the lta to a local cache resulting in the viewer being unable to display it. the original study on the lta is unaffected. in icea version 8.80, the pixel offset algorithm for images changed from absolute to relative offset. in normal operation, the new offset algorithm presents no risk. however, a pixel offset issue can occur when running a heterogeneous mix of icea versions spanning the lta and fic. more specifically, the issue can occur when running a pre-8.80 version of the lta with an 8.80 or later version for the fic. if prior studies are not available for viewing, this may lead to delay in treatment for the patient, however there are no reports of injuries as a result of this issue.
Acción
Merge has a released software fix available for this issue. In the interim, Emergo is advising users of the following workaround. Do not run a mix of pre-8.80 software for LTA and an 8.80 version or later for the FIC. When prefetching, send uncompressed studies from the LTA to the FIC. Restore images manually from LTA using the webadmin tool. This action has been closed-out on 22/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This action has been initiated due to potential incorrect display of mammographic measurements. the problem is that there is variability of how the estimated radiographic magnification factor (ermf) is provided in the dicom header data. when measuring a lesion on an unmagnified mammography image then performing the same measurement on an image magnified by the hologic imager (different image) the measurements are not the same. use of this product may lead to additional imagining, such as mri and/or biopsy follow-up, before referring a patient to any surgical procedures. particularly if an mri or ultrasound is done the incorrect measurements would be identified as erroneous. this may result in a delay in diagnosis or treatment or patient misdiagnosis.
Acción
A software upgrade will be implemented as a permanent correction. In the interim, users are advised not to use Merge PACS mammographic measurements until upgraded. The ability to create any measurements and annotations are controlled by together by a set of privileges which should be disabled until upgraded. This action has been closed-out on 22/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This recall has been initiated due to an issue in which the patient name in the halo title bar may not update to match the name on displayed images due to the java running out of memory. this may result in a mismatch of the displayed patient name on the halo title bar and the displayed images. this may result in a delay in diagnosis or treatment or patient misdiagnosis. there have been no reports of injuries as a result of this issue.
Acción
A released software fix available for this issue. A software update has been released which adds a warning message to the user interface for the user to close some viewers whenever the Java memory usage size exceeds 97%. In the interim, Emergo is advising users to ensure the correct patient name is displayed in the Halo title bar. This action has been closed-out on 22/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This recall has been initiated due to merge pacs inability to display presentation states on prior comparison studies generated on 3rd party systems or that have been migrated from office pacs. these presentation states are known as foreign presentation states. pacs 6.5.5 introduced the feature to be able to display foreign presentation states. however this feature was only available on the primary study in any given viewer instance. it did not apply to prior comparison studies that were opened in the same viewer. users might assume that if the annotations are available in the primary study, they would also be shown if available on the prior comparison studies.Use of this product may cause a user to believe that there was nothing significant seen in the prior image which may result in improper treatment. there have been no injuries reported as a result of this issue.
Acción
Emergo are advising users to open prior comparison studies in the secondary viewer to check if there were annotations and read the report, or visit notes pertaining to that study to see if there are any noted findings that are otherwise not apparent. Emergo will be implementing a software upgrade as a permanent correction. This action has been closed-out on 23/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This recall has been initiated due to an issue in icea which could result in unrecoverable loss of data when using tiered storage on icea. the issue can arise if a study has purged from tier 1 (i.E. via high water mark) and only resides in tier 2 and then the study is requested to be updated.In a tiered storage environment older data (less frequently accessed data) is staged to a second storage tier for long term storage. this staging process frees up space on the first storage tier for newer data. in rare circumstances, where the data that exists only on the second tier needs to be accessed, a software issue could lead to data being purged from both the first and second tier resulting in data loss. this issue may result in an archived study not being available for future viewing (i.E. as a prior study for comparison purposes, etc.). if prior studies are not available for viewing, this may lead to delay in treatment in determining the progression of the disease.
Acción
Emergo is advising users to create a new object and remove the reference to the original version in order to prevent the issue from occurring.
Emergo will be implementing a software update as a permanent correction. This action has been closed-out on 22/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
It was identified that the phil container (syringe) may elute unintended elements (metals) into phil device formulation. this elution may discolour the phil device, or may not change the appearance of the device. at this point no adverse events related to product deficiency or specific patient reactions were reported to the manufacturer. microvention has not currently identified possible risk to patients associated with previous uses of phil devices. culpan medical is in negotiations with the tga regarding the need for any further actions.
Acción
Customers are advised to identify and quarantine all affected devices in their possession and return them to Culpan Medical. Recommended patient follow-up for doctors: continue to collect and report to the Therapeutic Goods Administration and the manufacturer any Adverse Events/Patient Reactions. This action has been closed-out on 10/05/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Within the sureloc application, under sureloc preferences, there are two grid options: a generic grid or the ge 8-channel curved grid. a generic grid is a flat grid of 2 centimeter holes. there is no limitation on the number of blocks. selecting the incorrect grid or using an unsupported grid could result in an incorrect biopsy or missed target. there is a chance that a repeat biopsy may be required.
Acción
Emergo is advising users to ensure a verification scan is completed as per the User Guide to confirm correct placement prior to undertaking a biopsy. Users are also advised that if they are using a grid outside the two defined options, please contact Merge support. This action has been closed-out on 27/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Siemens healthcare has identified a software defect in the stratus cs acute care diagnostics system regarding testpak calibration and quality control (qc) status when a testpak is due to expire within 48 hours. depending on the calibration status, either an above assay range (aar) or an inaccurate value could potentially be reported when running a testpak that is due to expire within 48 hours. the probability of occurrence is extremely unlikely and other factors such as previous results, patient presentation, and other diagnostic testing would initiate clinical questioning and reduce the potential for injury.
Acción
Siemens Healthcare is advising users of the following:
1. Do not use TestPaks that are due to expire within 48 hours, OR
2. Check Reagent Status to ensure all TestPaks in use have valid calibration expiry dates beyond the TestPak lot expiry date, AND
3. If the laboratory performs routine QC and if using a TestPak that is due to expire within 48 hours, ensure that scheduled QC is performed before running a test.
Siemens Healthcare is currently developing software updates to address this issue and will be providing new information as it becomes available.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This recall is due to a necessary modification to the cadstream difference threshold when used in conjunction with ge phased array uniformity enhancement (pure) for dynamic mri imaging & a lack of notification when cadstream detects the pure filter has been used.The pure feature is designed to minimise coil intensity variations through a calibration process & may affect the signal intensity values of images. for dynamic series, cadstream kinetic analysis relies on a consistent image acquisition protocol for each individual series in the dynamic series. if pure is applied to individual phases, it may change signal intensity values for the individual series, thus affecting the kinetics. this may result in a change in the amount of colour in the cadstream angiomap. scanning protocols and/or contrast agents that are inconsistent with background filter multiplier settings may result in a sub-optimal angiomap. this may result in a delay in diagnosis or treatment, or patient misdiagnosis.
Acción
Merge has released software fix for this issue. The CADstream software fix will detect when a PURE filter is being used and display a notification to the end user. Emergo is providing users with a set of work around instructions to follow as an interim measure. This acion has been closed-out on 27/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
When using the perpendicular line tool, there is an option to 'snap' the lines together, which prevents the perpendicular lines from extending past the straight/base line. when a perpendicular line measurement is made and saved in a plan, the line measurement value changes when the plan is reloaded. this is due to when the “snap to line” feature is enabled, it doesn’t apply automatically when the perpendicular line is drawn. it only gets applied when the saved plan is reloaded, so to the user, the measurements look different from what was saved. however, in each case (before/after “snap to line” is applied), the line measurement is accurate.If the line end point is within 20 pixels of the base line, it will adjust its location to snap perfectly to the base line. this may adjust the length and corresponding measurement of the perpendicular line when the plan is reopened.This may cause delay in diagnosis or treatment of patient, however the actual measurement of the line is accurate.
Acción
Emergo is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent correction. This action has been clsoed-out on 27/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
Unviewed images may not display after the last hanging protocol (hp) step when the user preference setting "show unviewed images after the last hanging protocol (mg only)" is selected. this can occur if the last hp step was skipped. this is most commonly encountered if there are additional views created for the study.This may impact diagnosis when images are unavailable for viewing, however there have been no reports of injuries as a result of this issue.
Acción
Emergo is advising users to not have the red-x icon available in the reading physician's toolbars to close the study. This will trigger a warning message that there are unviewed images available.
Emergo will be implementing a software update as a permanent correction. This action has been closed-out on 27/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This recall has been initiated because studies that have qc, pde or hl7 adt updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. use of this product may result in demographic changes to studies not being passed downstream to other pacs servers whether in-house or used for tele-radiology transfers.Not receiving updated demographics or image content may result in delay in diagnosis or treatment of the patient or misdiagnosis as the physician may not receive the required study. there have been no reports of injuries as a result of this issue.
Acción
Emergo is advising users to use DICOM transfers rather than telmed transfers to receiving sites. If there is a valid failure, retrieve the study from archive and resend. It is recommended that logs are reviewed to ensure that all studies have been sent to receiving physicians. Emergo will be implementing a software correction as a permanent correction. This action has been closed-out on 22/02/2017.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
Notas adicionales en la data
Causa
This action has been initiated because the cross reference lines a.K.A. cut lines or localiser lines may not display properly. this is due to math error when calculating the cut line position for studies with extremely high precision in the dicom tag image orientation patient (0020,0037) containing values of greater than 15 significant digits. the patient tag on affected images includes the value "e-16". when the problem is encountered the cross reference lines will move erratically as the user stack scrolls through the study. this may impact diagnosis when images are unavailable for viewing.
Acción
Merge is working on correcting the issues and will inform customers once a fix is available. In the interim, users are advised that in order to view the study with the cross reference lines, it is recommended to view the study on another workstation of the modality device. Also, examine the image orientation patient tag to see if there are values with "e-16" included to see if a study in question could be affected. This action has been closed-out on 27/02/2017.