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 following issues have been identified which may result in additional patient scanning & therefore additional radiation doses. there have been no reports of injuries as a result of these issues;- scan length changes with a change in the field of view (fov);- the doseright algorithm calculates a water equivalent diameter that is larger than measured on a cylindrical phantom when an 80 kvp or 120 kvp surview is used. this will result in a mas value for the scan that is higher than suggested when using a 100 kvp or 140 kvp surview. (note: the reported mas and ctdi values are correct for all scans & surviews);- wrong scan time estimation due to incorrect intergration time causes the surview scan near 184mm &135mm may result in unexpected scan start positions; &- there may be a discrepancy between the calculated reconstruction length & the actual scan length which may result in the inability to reconstruct the raw data. offline reconstruction of the raw data is also not possible.
Acción
Philips is providing users with work around instructions to follow as an interim measure. A software upgrade will be implemented as a permanent 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
Baxter has been advised by dräger of isolated cases in which the unwanted release of evaporating agent was observed by users at the end of the filling procedure. dräger has identified two potential root causes for the reported issues of unwanted release of evaporating agent after filling:a. non observance of the correct filling procedure, especially with regards to the 2 to 3 seconds pause before bottle removal after filling; andb. high friction of the drug bottle valve inside the vaporiser opening may delay closing of the bottle valve after fillingthe release of unintended evaporating agent may lead to spraying of aerosol into face and eyes of the operator. eye contact with volatile anaesthetics can result in serious irritation; immediate flushing of eyes and consultation of a physician is recommended.
Acción
Baxter is advising users to adhere to the product IFU when handling the device. Recently updated Material Safety Data Sheets (MSDS) of Desflurane manufacturers recommend the wearing of safety glasses when handling these substances.
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 determined that the threshold set for hla-c eres probes 380, 382, 384 and 385 in lot number 10235b are set high and may result in false negative probe results. the probes resolve the following cwd alleles:• probe 380 resolves c*03:06• probe 382 resolves c*12:13• probe 384 resolves c*01:08 • probe 385 resolves c*08:06.
Acción
Diagnostic Solutions is advising users a correction will be made by replacing the old HLA-C eRES MATCHIT! EXP file with a revised MATCHIT! EXP file, which is specific to this single lot. This action has been closed-out on 02/02/2017.
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
During recent evaluations of the philips mobilediagnost wdr 2, philips has identified a potential issue that could result in unnecessary radiation exposure to the patient under certain conditions. 1. the system may sporadically apply the default x-ray exposure parameters for an adult (patient type: “normal”), even though the patient type “newborn” was selected and is displayed in the generator control area of the eleva user interface.2. under certain conditions, the detector might not be ready for examination. released x-ray might lead to an image with artefacts and a retake is required. while the attachment process is running, the detector might be too short in front of the ir (infrared) sensor and the problem of the washed out images can appear if an exposure is taken right after that.
Acción
Philips is providing work around instructions for users to follow as an interim measure. A software upgrade will be implemented as a permanent correction.
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
During production two different length fasteners were found to be made of stainless steel rather than the specified alloy steel. the nonconforming fasteners may have been used to manufacture ingenuity ct systems. the fasteners are used to secure sub-components of the adjustment cradle within the system gantry. analysis has concluded that the nonconforming fasteners continue to meet the tensile safety factor requirements for the application. however given the material characteristics of stainless steel, these fasteners may not be re-used (re-torqued). since the adjustment cradle requires periodic adjustment, it is expected that the nonconforming fasteners would require re-torqueing at some point during the system’s lifetime. repeated re-torqueing of the stainless steel fasteners could introduce stresses that approach the ultimate yield strength of the fasteners. there have been no reports of injuries.
Acción
Philips is advising users that a field service technician will replace the affected screws on all affected systems.
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
Investigation of complaints received has concluded that when using elia ccp well (14-5515-01) in combination with elia igg conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01), anti-ccp-signals can be elevated for the listed conjugate lots.The positive bias of the elia ccp test will change a small percentage of test results from negative to equivocal and equivocal or high negative to low positive.Testing on clinical samples of both confirmed rheumatoid arthritis (ra) patient sera, healthy blood donors and other disease controls resulted in < 1% of the samples changing from negative to positive, according to current cut-off ranges (total study includes 472 samples). the results of the assay evaluation studies performed confirm the variance to be within current clinical performance, and it is concluded that the clinical impact of the observed bias is negligible.
Acción
The sponsor is advising customers to stop using EliA CCP Well (14-5515-01) in combination with EliA IgG Conjugate (83-1017-01, 83-1005-01, 83-1002-01 or 83-1018-01) of the affected lots as stated. The sponsor will provide unaffected EliA IgG conjugate lots as soon as they become available. This action has been closed-out on 15/02/2017.
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
The manufacturer, volcano corporation has become aware of a system incompatibility issue between the affected systems and hospital network scans. in specific circumstances, a system will encounter unexpected data from the hospital network and the system will need to be manually rebooted. this condition can occur any time, including in the middle of a patient procedure.The system incompatibility issue occurs when hospital staff scan their networks for potential security vulnerabilities and the user is required to manually reboot the system. if this issue occurs during an active procedure, a reboot would result in a delay in the procedure and/or abandonment of the use of ivus and ffr/ifr functionality in the procedure. there have been no reports of injuries associated with this issue.
Acción
LifeHealthcare is providing users with work around instructions to follow as an interim measure. A correction is being developed as a permanent correction. This action has been closed-out on 24/05/2017.
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
Siemens healthcare laboratory diagnostics has confirmed that all in date lots of advia centaur tni-ultra exhibit a greater than 10% change in results in samples with biotin levels up to 10 ng/ml (41 nmol/l). the instructions for use (ifu) states that specimens that have up to 10 ng/ml (41 nmol/l) of biotin demonstrate = 10% change in results. the biotin level in a general population is approximately 0.3 to 1.0 ng/ml (1.2 to 4.3 nmol/l).The biotin interference is proportionate across tni concentrations; therefore, the ability of the assay to detect serial increases or decreases of tni is maintained.
Acción
Siemens is advising users that the Tnl-Ultra assay can continue to be used, however, users should be aware that patients who are taking biotin supplements may exhibit a slightly elevated TnI-Ultra result; however, the ability of the assay to detect serial increases or decreases of TnI is maintained.
A review of previously generated results is at the discretion of the Laboratory Director.
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
Alcon is conducting a recall for specific lots and catalogue numbers of its centurion fms (fluidics management system) pack due to the possible presence of a moulding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line. the use of products from the affected lots may result in a small air leak and corresponding reduction in vacuum performance, leading to inability to achieve or reach maximum targeted vacuum and reduction of holding force at the distal end of the phaco tip.There is a risk of thermal injury, capsular bag tear, tissue damage, corneal endothelial cell damage, corneal oedema, retinal tear/detachment, and endophthalmitis. there have been no reports of injuries associated with this issue.
Acción
Alcon is advising users to review inventory and stop using the affected product for replacement with unaffected 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
The following issues have been found in mx 16-slice systems.1) during the filming operation, the clipboard used for copying and pasting images is not cleared between patients. if the operator fails to copy the current patient’s images before pasting, a previous patient’s images may be present in the clipboard and be copied onto the film of the current patient. 2) during the bolus tracking scan, if the auto voice in tracker scan is enabled, the tracker scan will be aborted unexpectedly and the diagnostic scan after the tracker scan needs to be manually started.3) if the scan protocol with sas (spiral auto start) function is selected to plan the scan, the sas option may not be displayed on the contrast tab of the scan protocol parameter area or the sas option is displayed but not enabled as pre-configured in the protocol. this issue only occurs on the first helical scan after system startup that applies sas function.There have been no reports of injuries.
Acción
Philips 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 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
The manufacturer, accriva diagnostics has confirmed that some avoximeter 1000e instruments shipped to customers from july 2015 and april 2016 may have been sent to customers with the diagnostic mode enabled. with the diagnostic mode enabled, users could mistakenly unlock features in the instrument software through a specific sequence of keystrokes. if these features are altered, there is a potential for erroneous results to be displayed. to date accriva has not received any reports of injuries or harm to users due to this issue. instruments in diagnostic mode perform per accriva’s specifications and all data generation is equivalent to those instruments properly set to user mode.
Acción
Zoll Medical is providing instructions for users to be able to identify the affected instruments. In the case where an affected instrument is identified, users should contact Zoll Technical Services to correct the settings. This action has been closed-out on 03/02/2017.
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
An internal technical investigation by oxoid limited, has identified that the affected lot may give a weak false positive line with no h. pylori antigen present, making interpretation of test results more difficult than with previous batches. continued use of this lot may result in a delayed or false positive results reporting.
Acción
Thermo Fisher is advising users to inspect stock and remove any remaining product of the affected lot number from use. A credit note will be issued.
A review of previously generated patient results is at the discretion of the Laboratory Director. This action has been closed-out on 03/02/2017.
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
The product recall is implemented by the manufacturer, alphadent nv as a result of the cancellation of the company's ce certificate of conformity. alphadent nv has not received any injury reports relating either directly or indirectly to the medical devices (ceka attachments) subject to this recall. however, as a precautionary measure and in order to ensure compliance with applicable legislative requirements, alphadent nv has decided to initiate a recall of the concerned medical devices manufactured from 13 september 2013 with batch number 13091 and subsequent batches.
Acción
Alphadent is advising users to inspect stock and quarantine any remaining stock for return or 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
Based on complaints and a subsequent investigation, the manufacturer has detected an increased frequency of users reporting difficulty with stent deployment and/or separation of the bond between sections of the device outer member.The reported issues may result in an intra-procedural delay for the patient while a replacement device is prepped. partial stent deployment may result in vessel damage (carotid dissection or perforation, vessel spasm) requiring unplanned percutaneous or surgical intervention to prevent permanent injury or impairment. in most severe cases, partial stent deployment may potentially result in transient ischaemic attack or stroke.Cordis have isolated the issue to product manufactured between 27 april 2015 and 22 november 2015. product that has been manufactured after 22 november 2015 is not affected.
Acción
Users are asked to immediately identify and quarantine all products listed in the customer letter in a manner that ensures the affected products will not be used and to complete the attached acknowledgement form, follow the instructions given and to forward this notice to anyone in your facility that needs to be informed. This action has been closed-out on 04/05/2017.
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 as a limited number of sealed test strip vial boxes from the affected trueresult blood glucose test strip batch may include an open test strip vial. test strips contained within open vials are exposed to the outside environment, which can adversely affect the strips performance. in particular, test strips exposed to the environment may provide falsely low blood glucose results. falsely low blood glucose results may lead to undetected hyperglycemia (high blood glucose) and result in improper treatment.Action based on falsely low results may raise blood glucose levels further, resulting in potentiated hyperglycemia which may require medical intervention.
Acción
Nipro is advising users to inspect stock and quarantine any remaining stocks of the affected batch for return. This action has been closed-out on 03/02/2017.
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
The manufacturer has identified a software issue which may lead to incorrect patient positioning during treatment. in a specific scenario the software may prompt the user several times to move the hexapod to its drive (*start) position. if the user follows this request the hexapod will move to drive (*start). in a consecutive step iguide shows hints to move the couch top with the precise table back to the initial imaging position. however, this position is reached only with a coarse movement. the final fine adjustment move, executed by the hexapod, is missing. the coarsely reached imaging position becomes the new registered position for the actual position error correction (pec) movement to the target position. a theoretical additional error of max. ± 2 mm in three dimensions, in respect to the true target position, can occur due to the missing fine movement.
Acción
Electa advises users to avoid imaging in the PARK (*LOAD) position. If the user has performed imaging when the HexaPOD is not in the DRIVE (START*) position, cancel all move to DRIVE (START*) requests. Thus the HexaPOD remains in the imaging position. If the user then applies the PEC the HexaPOD will reach the target in the specified accuracy. The movement to the target will be a combination of Precise Table and HexaPOD moves. In case of any doubts perform a verification scan.
A software update which will correct the behaviour of the affected iGUIDE versions 2.1 and 2.2 will be provided to the affected customers free of charge as soon 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.