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 by emergo that some raystation/rayplan users have commissioned machines with erroneous beam profile correction parameters. these parameters affect the dose calculated in corners of large or off-axis fields. to the best of our knowledge, the issue has not caused any patient mistreatment.
Acción
Emergo is requesting that users:
Always validate the beam model for all clinically relevant fields, including, but not limited to, large and off-axis fields, before the system is used to create clinical treatment plans.
- Carefully review all beam model parameters before commissioning.
- Be aware that the Beam profile correction values may need to be adjusted in order to correctly model the primary collimator that limits the dose in the corners of large or off-axis fields.
- Review any existing photon beam models to ensure that the actions above have been properly performed.
Please educate physics staff about these user responsibilities.
Inspect your product and identify all installed units with the above software version number(s), then confirm that you have read and understood this notice by replying to the notification email.
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
Emergo have identified the potential for the tethered plug on the hub inadvertently opening after closure. the tethered plug not staying closed in the feeding tube hub may result in a leak of nutrition from the feeding tube. as described in the instructions for use (ifu) provided with the product, sterile water should be the only liquid that would leak from the feeding tube when the user flushes the tube before and after use. to date, no adverse events related to this issue have been reported to neomed.
Acción
Emergo is requesting that users examine their inventory for product subject to this recall and quarantine all affecetd stock until a return can be facilitated as per the instructions given in the Customer Letter.
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
Stryker australia has discovered that two (2) lots of tritanium-pl cages, part number 48950066 (lot # a8am) and part number 48954066 (lot # a8t2), were shipped and sold to australia without market release approval. the tritanium-pl cage product family has been registered and approved in australia. however, the specific part numbers 48950066 and 48954066 were not registered in australia.
Acción
Stryker Australia is requesting recipients of the letter to confirm whether they possess any affected stock and to inform any parties who may have received affected stock and to inform Stryker of this using the supplied response forms.
A hazard alert is also being issued.
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 clinical diagnostics australia has identified the potential for positively biased sample results to occur when using certain vitros na+ slides. results for serum/plasma and urine samples obtained using impacted vitros na+ slides may be positively biased and quality control fluids may be outside of the expected ranges. the amount of bias in the vitros na+ method is dependent upon multiple sources of variability.Two separate issues have been identified:- vitros na+ slides, gens 8 & 13: positively biased urine sample results; and - vitros na+ slides, gens 13, 14, 16, 17 & 18: positively biased serum or plasma sample results.
Acción
Ortho Clinical Diagnostics is advising:
For VITROS Na+ Slides, GENs 8 & 13:
- Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 8 & 13, regardless of sample type used for testing.
For VITROS Na+ Slides, GENs 14, 16, 17 & 18:
- Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 14, 16, 17 & 18, regardless of sample type used for testing.
- It is acceptable to continue to use remaining slides until your replacement order arrives provided both of the following criteria are met:
1. Calibration is successful and Quality Control results are within acceptable limits; and
2. Distribution of normal results for serum or plasma samples are centred within the established reference interval for the laboratory.
If at any time during use of remaining slides, any of the above criteria are no longer met, discontinue use and notify the requesting physician for all previously reported Na+ results that are likely affected where applicable.
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
B. braun has been identified that some of the items in specific batches have damaged packaging which may affect the sterility of the products. no specific monitoring of patients is recommended at this time.To date, there have been no reports of any adverse patient outcome which could be associated with this potential sterility issue.
Acción
B. Braun is requesting customers:
1. Identify, quarantine and return affected devices;
2. Do not use affected devices anymore;
3. Patients with affected devices in use should be monitored carefully;
4. Inform the responsible personnel in the relevant facilities; and
5. Confirm receipt of the correspondence as per the instructions given in the Customer Letter.
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
Philips have identified that when the operator or a bystander touches the area of the inner part of the vertical sliding column (on which the tube arm moves up or down), without paying attention of the tube arm movement, the operator's fingers can be pinched.
Acción
Philips are advising that they will install a new label on affected systems. A Philips Service Engineer will contact customers when the Field Action Kit is available to be implemented.
In the interim, customers may continue to use their systems, provided they follow the Instructions for Use which outlines that users keep all body parts and clothing free of the equipment to avoid getting caught or trapped within the moving components.
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
Ge healthcare has identified that the latest on-site software version may not have been reinstalled at some sites after service activities were performed that required software to be reloaded. if the incorrect version is loaded on the system, the images can be flipped left/right and/or there can be patient data mismatch.
Acción
GE Healthcare are advising they will inspect all affected systems and ensure the proper software version is installed. GE Healthcare will check systems remotely (on-line) where possible, and will visit sites if a remote check is not possible.
GE Healthcare will advise users after the software version has been inspected and if any correction is needed. If a correction is needed, a service representative will contact users to arrange for this correction.
Users may refer to the information in the Customer Letter to check their system software version. If an impacted system is identified, users are advised to contact their GE representative immediately
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 that the product visionaire lightweight alignment rod is oversized, preventing mating with the visionaire alignment connector.
Acción
Once the recall acknowledgement has been received and there is product to be retrieved, a Smith & Nephew Representative will go to the hospital to retrieve the affected items are provide replacement products
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
Baxter healthcare have identified the potential for a leak to occur at the tube to cap junction of the in-line blood set with filter (mmc2433). preliminary investigation has shown that this issue is due to the combination of cap dimension variability, especially on lower limit, and insertion depth of the cap into the tube on the lower side.To date, no complaints have been received as a result of this issue.
Acción
Baxter is advising customers to identify and quarantine affected product from their facility. Baxter will arrange return of product from impacted users.
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
Device technologies has been notified by the manufacturer, symmetry surgical, of a product complaint regarding a monopolar pencil and cord. the reporting site observed some anomalies in the packaging seal resulting from the package’s contents having migrated near or within the seal area. this condition increases the risk of the seal’s integrity being compromised. testing indicated that the defect is introduced during the packaging operation and will not result from shipping or normal handling conditions.
Acción
Device Technologies (DTA) is advising customers product is acceptable for use if it is visually confirmed that the package's contents do not interfere with the packaging seal and the seal is intact.
Users are advised to either:
- Inspect all affected product in accordance with the inspection instructions outlined in the Customer Letter. Product that does not meet acceptance criteria should be shipped back to DTA for credit. If users are uncertain if product is acceptable it is advised to return the item; OR
- Ship stock held of the Olsen Single Use Electrocautery Forceps/Pencils/Cords back to DTA for credit.
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
Philips have identified that the first time an operator selects a new procedure type during a single examination, the shutter position resets to the open position for the new procedure type. if the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
Acción
Philips is advising this issue will be resolved in a software update, expected to be available in the second half of 2018. Philips will notify users when this software update is available.
Until a software revision that corrects this issue becomes available, users should verify that the desired shutter position is set when performing the run after the first time the procedure type is changed during a single examination. This can be accomplished by first selecting a different procedure and then reselect the original procedure on the Xper Module or on the Data Monitor.
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
Nxstage has identified a potential risk of electrical fire, in the event fluid leaks into the power receptacle on the back of the express fluid warmer. this risk exists at any time whilst the warmer is plugged in. nxstage has received 7 reports of smoke, sparks or flames coming from the express fluid warmer since 2016. there have been no adverse health consequences or medical interventions reported as a result of this issue.Given the occurrence of these incidents, the instructions for use (ifu) are being updated with a warning about fluid bags and fluid near the warmer, along with instructions on how to minimise this risk.
Acción
NxStage, through Regional Health Care Group have taken the decision to
replace the Instructions for Use with an updated IFU.
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
Ambu australia has received reports regarding the potential for the ‘cushion seal to separate from the mask’. to date, there have been no adverse health consequences or medical interventions reported due to this issue.
Acción
AMBU is advising customers to inspect stock and quarantine all AMBU UltraSeal II Anaesthetic Masks. AMBU will arrange collection of all the affected masks
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
Philips has received reports of instances where after a continuous operation of more than one and a half days, the image on the flexvision large screen monitor froze for about 15 seconds. thereafter, the system restored itself and was fully operational again.This is only applicable to allura systems with a flexvision large screen monitor. all other monitors to the system are not affected.To date, philips is not aware of any injuries that may have occurred due to this issue.
Acción
Philips is advising this issue will be resolved in a software upgrade, expected to be available by the second half 2018. Users will be contacted by Philips when the software is available for installation.
In the interim, users are advised to restart the system at least once per day to prevent occurrence of this issue.
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
Medtronic have identified that when an ap-vs interval measures 100-109ms during a short, nightly device check, a single reset is generated. this reset produces a non-programmable, wireless carealert, but does not alter device therapy. if the device experiences more than five resets due to this timing sequence between in-clinic device interrogations, a full reset (sometimes referred to as a power on reset) will occur. by design, a full reset automatically reverts device operation to rv-only pacing at vvi/65 until the next programmer session is conducted – at which time the full reset condition can be cleared, and the device can be reprogrammed to its prior settings.
Acción
Medtronic are advising that a software update, Application SW040 Version 8.1, is available for installation onto all CareLink Model 2090 and Encore programmers to eliminate this issue. Once installed, an in-clinic device interrogation will update the patient's device automatically to prevent this timing interaction from generating a reset.
Surgeons are advised:
- To contact their local Medtronic Representative to schedule installation of the updated Percepta CRT-P Application Software onto Medtronic 2090 and Encore Programmers.
- For a patient who has been implanted with a Percepta CRT-P device, consider scheduling an in-clinic device interrogation as soon as possible following installation of the updated application software, for the patient’s device to receive the automatic update.
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
Medtronic has identified the potential for loss of high voltage and anti-tachycardia pacing therapy in entrust implantable cardioverter defibrillators (icds) as they near elective replacement indicator (eri) voltage. affected devices may display an immediate “end of life” (eol) observation with no prior alert (implanted electronic heart devices are designed to alert physicians and patients as the device battery depletes). though no elective replacement indicator (eri) alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time eol observation. bradycardia (pacing) therapies will continue to operate as expected. medtronic has received no reports of patient deaths or serious adverse events due to this issue.
Acción
Medtronic is advising the below for surgeons following consultation with the Independent Physician Quality Panel:
- Schedule an in-office patient follow-up as soon as possible to assess the potential for this issue per the steps outlined in the Customer Letter.
- Ensure the Excessive Charge Time EOL…and the Low Battery Voltage ERI… Patient Alerts have been programmed to “On-High”.
- Instruct patients to contact your office if they hear device alert tones. Consider utilising the “Demonstrate Tones. . .” function to ensure patients recognise the audible tone.
- If this issue has occurred, an “EOL: replace device immediately” Observation will be displayed on the QuickLook report. Schedule device replacement immediately.
The Customer Letter provides information for surgeons to ensure high voltage therapy remains as the device battery voltage approaches its 2.61V ERI threshold.
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
Becton dickinson (bd) has received reports of leakage which could result in the potential exposure of hazardous drugs to the healthcare worker during preparation, transport or administration.This defect was noted by customers during product use. leakage was observed between the connector to the secondary set spike and the tubing to the spike joint. the defect cannot be detected by visual inspection only. 8 reports relating to this issue have been received in australia. to date, no reports of injury have been received in australia.
Acción
BD is advising customers to immediately review inventory and quarantine affected product. BD will arrange collection of affected stock from facilities.
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
Cook medical has identified the diagram on the product label of the chorion villus biopsy needle set (k-cvns-1821-robinson-et) is incorrect. it shows that the 18ga needle has an echotip, and the 21ga needle does not, whereas the product is designed such that the 21ga needle has the echotip and the 18ga needle does not.The tip of the larger gauge guide needle is likely to be visible on the ultrasound regardless of a non-echogenic tip. in the event that the labelling error resulted in a clinician expecting the echogenic tip to be present on the guide needle, instead of the sampling needle, the clinician may not be able to adequately identify the tip of the inserted access needle.To date, there have been no reports of harm relating to this issue.
Acción
William A Cook is advising customers to inspect stock and return affected product.
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 have identified that in the event of a short-circuit within the x-ray tube, a current leakage may cause an overload of the x-ray generator. if this current leak remains undetected it may cause damage to the generator by overheating after-which, taking an x-ray will not be possible.
Acción
Siemens are advising they will contact customers to schedule the installation of a Residual Current Device (RCD) on affected generators in order to detect current leakages.
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
Aidacare has identified a labelling error pertaining to electrical classification on the manufacturer id sticker – it is shown as class ii device when the device is class i. this mislabelling creates the potential for testing and tagging to be incorrectly administered on fl250 beds.The class is labelled correctly on the control unit under the bed.
Acción
Aidacare is advising that they will contact impacted customers to arrange for on-site correction.
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 olympus winter & ibe has updated section 7.9.1 gas sterilisation in the instructions for use for the wair100a and wair130a to include the following warning:“warningrisk of injury to the patient and usertoxic gasses can enter internal volumes of the product during gas sterilisation. the gasses can remain in the product and can leak out during use.· to remove toxic gasses, aerate the product sufficiently after sterilisation.”.
Acción
Olympus is requesting users:
1. Inspect their inventory for any WAIR100A or WAIR130A Infrared Telescopes within their control;
2. Remove any existing Instructions for Use (IFU) and implement use of the updated IFU;
3. Ensure all reprocessing personnel are informed of the additional warning. Please do not hesitate to contact your local Olympus Sales Specialist to organise additional training;
4. Complete the reply form supplied with the customer letter and email to RA@Olympus.com.au or fax to 03 9562 6438; and
5. If you have distributed or transferred any of the affected products from your facility to another, forward the recall letter to them and notify Olympus so that they can follow up with that facility directly.
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
Device technologies australia (dta) has been made aware by the manufacturer, vygon gmbh & co kg, of reported incidents where the stylet snapped upon removal when the user made a second attempt to remove the stylet from the catheter.
Acción
DTA is advising that the Instructions for Use (IFU) have been revised to provide further instructions concerning the removal of the Stylet.
The relevant segment is as follows:
"If difficulty is experienced removing the stylet stop, let vein rest for a minute and try removal again very slowly. Gentle flushing of the catheter with diluted lipid solution (preferred) or saline assists in stylet removal. If resistance still remains, withdraw catheter and stylet simultaneously".
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
Qiagen have identified an issue regarding the power branching printed circuit board (pcb) within the ez1 advanced xl instrument. occasionally this has the potential to trigger a malfunction of the instrument heater. nucleic acid extractions processed during failure of the instrument could be compromised and extractions need to be repeated.To date, no adverse events have been reported as a result of this issue.
Acción
Qiagen are advising they will replace the faulty component in all potentially affected instruments.
Until devices have been corrected, users are advised to complete the following test after every run:
1. Put any EZ1 XL Card into the instrument;
2. Select “3” in the main menu to select test functions;
3. Press ”2” in the test screen to choose the “Temp” operation;
4. Set the temperature to “40.0” degrees;
5. Press “START”; then
Observe the “actual” temperature which is displayed. This should rise to 40.0 C +/- 2 degrees within 2 minutes, and an “O” should be displayed next to the temperature value.
In the event that the “actual” temperature does not rise to 40.0 C, an “X” continues to be displayed next to the temperature value, this indicates that the instrument is affected by this issue. In this case the nucleic acid eluate from the previous run should be rejected and the sample reprocessed.
Contact technical services to arrange a replacement of the faulty component.
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
Elekta has identified that the margin tool in leksell gammaplan 11.1 systematically overestimates margin in certain areas of the volume. the root cause is that the margin algorithm calculates the expanded volume at a resolution limited to the original images resolution in the contours normal direction, resulting in an overestimation of the resulting margin volume in areas oblique to the contouring plane.
Acción
Elekta is requesting users consider implications of the described inaccuracy in use of the margin tool in Leksell GammaPlan.