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.
Notes supplémentaires dans les données
Cause
The control's open-vial stability claim for all constituents is "once opened, vials of chemtrak - h are stable for 14 days when stores tightly capped at 2-8deg c". the manufacturer has confirmed that one constituent of the control, glucose, does not meet this stability claim as the recovery of this constituent trends down prior to the stated open-vial usage. the open-vial stability claim of 14 days remains unchanged for the other glucose levels, chu20022a and chu20023a.
Action
Thermo Fisher are advising customers to continue to use Level 1 of the chemTRAK control after the initial thaw for a period of 5 days and discard the control after this period.
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.
Notes supplémentaires dans les données
Cause
Philips has received reported instances in which the table of the omnidiagnost system (od-eleva) suddenly started to rotate from 0 to 90 degrees (table arm down) with high speed. the cause of this unexpected rotation movement is related to an issue with the fixation of the upper and lower tilt actuator. this rotating movement cannot be stopped by the user.If the system rotates uncontrolled, there is a risk of injury for the patient on the table. a rotating table also might hit a user or bystander standing near the system.
Action
Philips is advising they will be in contact with users to replace affected components on the upper and lower tilt actuator in the impacted systems. It is expected that this action will commence July 2018.
In the interim, users should monitor the tables for any of the following, stop use of, and contact Philips immediately if they occur:
- the table height or tilt movement is not working;
- a cracking or snapping sound is heard during system operation;
- a blockade is experienced in the table height or tilt movement during system movements;
- the system is having an unexpected collision or the system had an unexpected collision in the past 2 months;
- a CPR stand that obstructed the system when in use,; or
- any (other) unusual system behaviour beyond the normal use of the system.
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.
Notes supplémentaires dans les données
Cause
Zimmer biomet has received an overseas complaint regarding the segmental proximal femoral body 38mm offset alleging that the hole on the superior lateral aspect contained debris. an investigation determined that the debris was from the machining process that was not adequately removed during the subsequent cleaning process.To date, no adverse events have been reported as a result of this issue.
Action
Zimmer Bioment are advising Surgeons to maintain awareness of this issue, however, there are no specific patient monitoring instructions beyond the existing follow-up schedule for patients who have been implanted with these units.
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.
Notes supplémentaires dans les données
Cause
There have been multiple vulnerabilities discovered in natus neuroworks software, which is used in natus xtek eeg medical products. the vulnerable devices contain an ethernet connection for data acquisition and connection to networks. under certain scenarios, these vulnerabilities allow a remote attacker to run arbitrary code on the device, including a denial of service attack.
Action
Life Healthcare is advising that this issue is resolved in an updated software version - Neuroworks 8.5 GMA2. This software will be installed for users by Life Heathcare either on-site or via remote access depending on system setup.
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.
Notes supplémentaires dans les données
Cause
Upon completion of a 6d workflow, the hexapod evo module may be in a tilted state, if it is moved to the position used for 3d (non-iguide) treatments. in a subsequent 3d workflow, a possible incorrect position of the patient, due to a tilt of the hexapod, may be difficult to detect without verification. this description is not relevant for an iguide workflow (6d). the problem occurs only when a user switches from a 6d to a 3d workflow without iguide.
Action
Elekta is advising customers the correct position will be reached when the command to move the HexaPOD to the predefined 3D position is repeated. Users must perform this additional step without a patient on the HexaPOD after each change from the 6D workflow to the 3D workflow. Please refer to the respective User Manual for details how to initiate the movement.
The manufacturer is currently investigating solutions to rectify this issue. Once available, Elekta will contact users to coordinate the required actions.
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.
Notes supplémentaires dans les données
Cause
Zimmer biomet has identified specific lots of znn and m/dn trauma guide wires may exhibit process monitoring failures related to the sterile seal on the packaging. a breach in the packaging seal could potentially lead to loss of sterility of the device.To date, no complaints have been reported as a result of this issue.
Action
Zimmer Biomet is advising customers to identify and quarantine affected stock as necessary. Zimmer Biomet will contact users to remove any identified affected product and provide replacement.
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.
Notes supplémentaires dans les données
Cause
Zimmer biomet has identified a single lot of tapered screw-vent implants that were inadvertently packaged with patient chart labels which incorrectly indicate tsvb10 lot number 63773888. all outer and inner labels are correct.
Action
For unused product, Zimmer Biomet is advising customers to return affected product.
For implanted devices, Zimmer is advising customers to update patient records with the correct part and lot number.
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.
Notes supplémentaires dans les données
Cause
Randox have confirmed that free kappa light chains in certain liquid assayed specific protein controls increase over the shelf life of the product. the quality control results which are not within range can lead to a delay in reporting free kappa light chains results.Free kappa light chains are used as an aid in diagnosis of monoclonal gammopathy of undetermined significance and for multiple myeloma through review of the ratio with free lamda chains. a short delay in reporting this result is unlikely to prevent diagnosis of these progressive diseases and therefore is unlikely to pose an immediate risk to health.
Action
Randox is advising users to be aware of the issue and place the Customer Letter with any remaining kits.
A revised IFU is also being supplied to users which outlines this issue to users under "Storage and Stability".
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.
Notes supplémentaires dans les données
Cause
Abacus have been notified by the manufacturer, bioarray solutions, that lot # 18-299-11-c contains a subassembly kit (mia fora ngs flex hla pcr kit 2 (lot 18-299)) with an incorrect expiration date of 2109-04-30 instead of 2019-04-30. no other subassemblies within lot 18-299-11-c are impacted and no other mia fora ngs flex 11 hla typing kit lot numbers are affected.
Action
Abacus is requesting users to identify impacted product and correct the PCR kit 2 expiry date to 2019.
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.
Notes supplémentaires dans les données
Cause
Fujiflm has become aware of a malfunction in the system where inconsistent mitral valve mean pressure gradient values are being reported. the values are only affected when measuring multiple velocity traces in patients with an irregular heart rhythm, with mitral and tricuspid valve stenosis, using the synapse cv measurement tools. multiple traces measured on the modality and transmitted to synapse cv are not affected.To date, there have been no reported patient injuries as a result of this issue. this malfunction does not impact the advances reporting system and there have been no reports of any other measurements or calculations being affected.
Action
Fujifilm is advising users not to perform sequential multiple velocity trace measurements for mitral, tricuspid, aortic or pulmonic valves in the Synapse Cardiovascular analysis package.
If averaging needs to be performed in Synapse Cardiovascular analysis package, users are advised to follow the steps outlined in the Customer Letter.
This issue has been corrected in Synapse CV 6.1.0 and higher versions
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.
Notes supplémentaires dans les données
Cause
Roche have been notified by the manufacturer, sysmex corporation, of a potential failure of power up due to a short circuit of the pcb of cv-50 power supply unit in the event a leakage occurs from the instrument or operator error. sysmex have identified that in rare cases, some fluid (approx 50ml) may leak from the xn-10 / xn-20 automated haematology analysers into the conveyor unit itself, resulting in short circuit of the power supply and subsequent malfunction of the conveyor. if this issue occurs, the system will stop and patient samples will require processing by manual measurement.Sysmex has received one complaint worldwide for this issue; none from australian customers to date.
Action
Roche is advising they will be in contact with customers to arrange for a technician to ensure the gaps on the outer covers of the CV-50 will be sealed with waterproof materials. This will prevent fluid from entering the power supply board.
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.
Notes supplémentaires dans les données
Cause
In march 2017, device technologies australia (dta) in conjunction with intuitive surgical sent correspondence (tga ref rc-2017-rn-00440-1) highlighting the proper use of the da vinci xi endowrist stapler release kit (srk) tool and providing additional information regarding the use of the instrument release kit (irk) tool as a backup if a srk tool was not available.Further to this, intuitive surgical has now developed an improved da vinci xi endowrist stapler release kit (srk) tool, which reduces the likelihood of breakage. please note that the instructions for use (ifu) remain the same.
Action
Device Technologies are advising they will be providing users with replacement SRK tool(s) of the new design. Two new SRK tools will be provided free of charge for each da Vinci Xi or da Vinci X customer using the EndoWrist Stapler system. Users should place all new SRK tools with their system and discard any previous versions in inventory. Additional SRK tools may be ordered via the standard ordering process.
Users are reminded to refer to the IFU for appropriate use of the device.
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.
Notes supplémentaires dans les données
Cause
Ge healthcare has identified that some ct systems may have a damaged cable that can expose 120vac to service engineers working inside the gantry. this issue does not affect patients or operators external to the equipment.When the gantry front cover is removed to allow servicing of components inside the gantry, cover dollies are used to manipulate the cover. during the removal or reattachment of the front cover, a bracket can contact an internal power supply cable and damage that cable’s insulation. this can expose the conductor of a 120vac power supply cable and electrify the cover dolly, thereby introducing the risk of an electrical shock hazard to the service personnel.
Action
GE Healthcare is advising they will be in contact with affected users to arrange for the correction to be implemented.
In the interim, the system may continue to be used as this issue does not impact patients or CT operators. Users should ensure service technicians are aware of the issue and to wear protective gloves when using the cover dollies.
GE Healthcare have updated the service manual to prevent recurrence of this issue in the event of a replacement of the cable in the future. Users should follow the instructions outlined on the Customer Letter to download the latest Service Manual.
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.
Notes supplémentaires dans les données
Cause
Magic mobility has been notified of a component issue resulting in the direct actuator control switching, through the jack input socket, to not function correctly.This issue may cause either an incorrect switch/actuator operation or an inoperable external switch/actuator. at the time of dispatch from magic mobility, any wheelchairs fitted with this joystick did not require the use of the jack input socket. the wheelchairs performance is not compromised in its despatched state.However, if in the future, a client wishes to use the jack for a switch, then the jack may not work correctly. this issue would be detected immediately and therefore poses no safety risk.
Action
Magic Mobility has identified and quarantined all affected serial numbers.
Those units currently with customers are identified and a replacement scheme for the affected component has been initiated. Magic Mobility will be contacting affected customers 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.
Notes supplémentaires dans les données
Cause
Bio-rad have received multiple customer complaints indicating that some analyte values in certain vials of liquichek urine chemistry control level 2, lot 68512, are recovering outside the package insert stated ranges, namely high cvs.The performance of level 1, lot 68511 is not impacted.To date, there have been no reports of injury or illness as a result of this issue.
Action
Bio-Rad is advising customers to inspect and quarantine affected units to prevent further use. Customers are advised to discard any remaining inventory of Liquichek Urine Chemistry Control, Level 2 Lot 68512 and MiniPak 395X Lot 68510 (that contains the level 2).
Users are advised to contact Bio-Rad to make arrangements for replacement or to alter any pending orders or shipments. The replacement stock of Liquichek Urine Chemistry Control Level 2 is Lot 65822.
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.
Notes supplémentaires dans les données
Cause
Philips has identified that five warning statements are missing from the instructions for use (ifu) for intellivue mx40 ifu software revisions b.05, b.06 and b.06.5x. if users are unaware of the hazards or limitations described in the missing warning statements, they may not properly assess or provide appropriate treatment to a patient being monitored using an intellivue mx40.These ifus are missing warning statements related to monitoring of patients with pacemakers and the interpretation of qt/qtc measurements that were present in earlier revisions of the ifu. a “warning” alerts users to a potential serious outcome, adverse event or safety hazard. failure to observe a warning may result in death or serious injury to a user or patient.To date, no patient harm has been reported as a result of this issue.
Action
Phillips will contact affected customers to provide a copy of an Instructions For Use (IFU) Errata. Customers are requested to attach the Errata Sheet to the first page of Chapter 6 of the 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.
Notes supplémentaires dans les données
Cause
Thermo fisher scientific has identified that the plain container patient information label adhered to specimen jars for specific lots is incorrect as it contains the phrase "10% neutral buffered formalin". the correct label is exactly the same, but without the "10% neutral buffered formalin" phrase. the product information on the box (contains the containers) and content label on the containers are correct.
Action
Thermo Fisher is advising customers to identify and quarantine affected product. Thermo Fisher will contact users to arrange replacement or credit of stock.
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.
Notes supplémentaires dans les données
Cause
Medtronic has identified certain clip gun magazines have failed to meet the requirement of post-sterile seal integrity. testing performed by medtronic showed that the packaging sterile barrier of the pmc manufactured magazine cm8902, does not comply with the applicable packaging standard for terminally sterilised medical devices.Whilst the instructions for use (ifu) state “do not use if package has been previously opened or damaged”, it is possible that the seal breach may go undetected by the users’ naked eye. to date, medtronic has not received any complaints related to a sterile breach or infection that could potentially be related to a sterile breach.
Action
Medtronic is advising customers to identify affected product and return any unused units to Medtronic. Instructions for return can be found in the Customer Confirmation Form provided with the Customer Letter.
Clinicians and their Patients who may have received the listed devices should monitor the patient’s condition to determine if there are any signs of infection. If this is the case, the patient should seek medical attention immediately to treat the infection.
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.
Notes supplémentaires dans les données
Cause
Signature orthopaedics has identified that certain batches may be mislabelled, with the packaged component's size not corresponding to the label. therefore, the product intended to be used for the procedure may not be included in the packaging.
Action
Signature Orthopaedics is advising users to quarantine affected stock for return. Replacement stock or a credit note will be 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.
Notes supplémentaires dans les données
Cause
Tp orthodontics has been made aware of incidents of device breakage as a result of stress overload. to date, no reports of serious injury have been received as a result of this issue.
Action
TP Australia is requesting customers:
1. Locate any of the affected lots identified in the table given in the customer letter and quarantine those products; and
2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or for a suitable refund, following 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.
Notes supplémentaires dans les données
Cause
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.
Action
DTA is advising that the Instructions for Use (IFU) has been revised to provide further instructions concerning the removal of the Stylet.
The relevant segment is as follows:
"In order to remove the stylet, disconnect between the T-Piece and catheter hub. If difficulty is experienced 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.
Notes supplémentaires dans les données
Cause
Starkey have been made aware of a single incident in the uk where an unattended child aged 7 months has required treatment to remove an earmould from the larynx. this is the first reported incident of its kind, the likelihood of such event is considered extremely low and on this occasion there was no long-term injury.There have been no reported incidents in australia relating to this issue.
Action
Starkey is recommending clinicians glue tubing in place for new mould orders manufactured for children up to the age of 36 months. Clinicians are advised to mark orders with "Glue-inTube" when patients meet this criterion.
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.
Notes supplémentaires dans les données
Cause
Siemens has identified an issue with artis pheno systems. if the c-arm is moved manually longitudinal to a fully extended position it may occur rarely, that the system's safety stop mechanism may be activated. as a result, the c-arm of artis pheno stops the movement and can drop up to 20 mm (0.8"). this can happen during an ongoing procedure.If this issue occurs, the system performs a safety stop. all c-arm movements are blocked and can only be reactivated by a field service engineer.
Action
Siemens are currently working on a solution to eliminate the root cause of the problem.
In the interim, users are advised to avoid driving the C-arm into a fully extended longitudinal position. A fully extended longitudinal position is reached when the stand arms are almost completely stretched out.
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.
Notes supplémentaires dans les données
Cause
The manufacturer, olympus winter & ibe (owi) became aware of complaints relating to signs of wear on the handle after sterilization using the sterrad and steris, ‘casp low temperature plasma sterilizer’. during their investigation, the manufacturer confirmed that these signs of wear (slight changes in colour and structure) at the handle had occured after the first time of sterilization. whilst the sterilisation has no impact on the electrical safety of the electrodes, it no longer meets the manufacturer’s material compatibility acceptance criteria when using the sterrad and steris sterilisation methods. to ensure the intended life expectancy of the device, the manufacturer deems the material as no longer compatible when using the sterrad and steris sterilisation methods, as such the ifu has been updated to change the compatibility to “incompatible” for the reprocessing methods sterrad and steris.
Action
Olympus is advising:
"To ensure the intended life expectancy of the device, the manufacturer deems the material as no longer compatible when using the STERRAD and STERIS sterilisation methods, as such the IFU has been updated to change the compatibility to “incompatible” for the reprocessing methods STERRAD and STERIS".
Users should inspect inventory for affected product and visually inspect the device prior to use as outlined in the IFU (section 5.1).
If users are reprocessing devices using the STERRAD or STERIS, please discontinue and change to using one of the compatible reprocessing methods. An updated IFU to reflect this will be provided to 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.
Notes supplémentaires dans les données
Cause
It has been identified by siemens that the large display does not show an image due to a technical problem. this might occur after the large display returns from power save mode. the large display stays black without showing an error message. x-ray is still possible.The problem occurs sporadically and only when the display is returning from power save mode. it does not occur during an ongoing procedure.
Action
Siemens is advising they will contact impacted customers to arrange a firmware update to correct this issue.