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
Boxes of discovery trays marked to contain child-sized and small-sized trays actually contain adult-sized trays.
Acción
Kerr Australia is asking users to return the affected 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
Hemocue has become aware of indications of in-correct high readings of hemocue glucose 201 rt and hemocue glucose 201 dm rt for the application of monitoring of blood glucose levels on pre-term neonates. on full-term neonates there are no similar indications but as a precaution hemocue has decided to replace all systems on delivery and neonatal wards with hemocue glucose 201+ or hemocue glucose 201 dm while investigations continue.
Acción
HemoCue is recalling affected devices and is replacing them with unaffected models
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 registered a number of complaints where lifting straps have not been correctly placed on the hanger and patients have fallen partially or completely out of the sling. the user manual has been modified to incorporate new instructions on how to attach the sling on the hanger.
Acción
The sponsor is providing work around instructions for users to follow, until the Instructions for Use (IFU) can be updated.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer has identified that in some situations a miscalculation may occur for the grey scale values in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms". the min/max value of pixel density in these functions is not correct for images with a pixel depth greater than 12 bit. the mentioned measurements shown in prior images are also not correct. all values which are calculated for images with a pixel depth less than or equal to 12 bits are correct.
Acción
Siemens is providing work around instructions until a software update can be implemented to permanently fix the issue. This action has been closed-out on 18/02/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer has identified that in some situations a miscalculation may occur for the grey scale values in the functions "region of interest", "pixel lens", "edge enhancement" and "histograms". the min/max value of pixel density in these functions is not correct for images with a pixel depth greater than 12 bit. the mentioned measurements shown in prior images are also not correct. all values which are calculated for images with a pixel depth less than or equal to 12 bits are correct.
Acción
Siemens is providing work around instructions for each issue and will be implementing a software update to correct the problem.
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
If multiple uncompressed images/clips are sent to the syngo dynamics server around the same time, it is possible for an image from a patient to be placed in another patient's study. the dicom data may belong to the correct patient, but the pixel data may belong to another patient.
Acción
Siemens is providing work around instructions until a software fix can be implemented to permanently correct the 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
The current directions for use (dfu) for extrude wash lists a working time that is not indicative of the actual performance of the product.
Acción
Kerr Australia is providing updated Instructions for Use (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
A customer complaint reports that the article 022.2630 nc screw for cares® abutment, zr02 and ifu contains an incorrect screw. the investigation has confirmed that there has been a mix-up and a limited number of articles 022.2630 nc screw for cares® abutment, zr02 and ifu incorrectly contain an rc screw and 022.4630 rc screw for cares® abutment incorrectly contain an nc screw. all of the affected lots are identified and stopped further shipment however the invesitgation indicates that these incorrect screws have been shipped in 9 cases 027.4650 cares® abutment set rc, ceramic and 87 cases 027.2650 cares® abutment set nc, ceramic and dental laboratory.This recall action was not notified to the tga before it was initiated by straumann pty ltd.
Acción
Quarantine and return affected product to the distributors.
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
Reports of heating at the ipg implantation site during charging of the spinal cord and deep brain stimulators. this is an update to the 'hazard alert' letter dated 05 january 2012 . in the updated letter, st. jude is providing updated occurrence rates, informing hospitals and treating clinicians of four instances of patient burns associated with charging the ipgs and additional patient management recommendations.
Acción
St Jude is providing information to implant / treating clinicians on how to manage the patients affected with this issue. For more information, please see http://www.tga.gov.au/safety/alerts-device-ipg-120924.htm
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
1) axis-shield poc as, the manufacturer of afinion crp system, warns that an information code (error code) which is displayed on the analyser screen might potentially be misinterpreted as a high crp result. 2) the crp concentration in frequently opened control vials may increase due to evaporation. therefore, the stability of opened vials of afinion crp control has been reduced from 8 to 4 weeks.
Acción
Alere is providing work around instructions and will be implementing a software 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
It is recongnised that there is an issue with the economist forte and the fit to the unit with the supplied power cord accessory. in some cases, the power cord moulding is too large to fit into the unit. it is necessary to state that there is no safety issue with the unit, other than the possibility of the device not working due to lack of power supply.
Acción
The sponsor is asking pharmacies to return all affected stock to their wholesaler. The sponsor is asking all wholesalers to quarantine affected stock for return.
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
There have been reports that the lower surfaces of the cancellous bone impactors are round, not flattened.
Acción
Quarantine and return affected stock to Synthes Australia
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 diagnostics has confirmed a decrease in onboard dilution recovery when using multi-diluent 1 that has been stored on board the advia centaur and advia centaur xp systems. this under-recovery has been observed in plasma samples with high bnp and tsh-3 values that require dilution to achieve results within the reportable range on the advia centaur and advia centaur xp systems.
Acción
Siemens is providing work around instructions for users to follow.
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
In some cases, the kleenspec disposable vaginal speculum may become damaged during shipping and handling, which may cause them to break during use.
Acción
Inspect stock and return damaged devices to Welch Allyn Australia.
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 alaris pump module may experience intermittent motor stall. most of the motor stalls reported appear to occur intermittently at high infusion rates (typically over 900 ml/hr) but carefusion cannot rule out the possibility of occurrence at lower infusion rates.
Acción
CareFusion is advising users to consider the clinical risk of using these pumps in high risk patients undergoing infusions at high rates and to have alternative pumps available. If a motor stall occurs the users are being asked to quarantine the pump and to contact CareFusion.
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
Architect toxo igg reagent lots 15070li00 (list number 6c19-25) are showing reduced specificity which may cause a shift to higher iu/ml values leading to increased grayzone and/or reactive results. the assay sensitivity is not impacted and current data indicated that no other lots are affected.
Acción
Quarantine and discard affected products. Abbott recommends discussing previous results with Laboratory Management and healthcare providers to determine if any further testing is required.
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
Guideliner catheter is being recalled due to a regulatory compliance issue. guideliner catheter has now been cancelled from the australian register of therapeutic goods (artg) because it should have been classified as a class iii medical device, not a class iia medical device in accordance with the therapeutic goods (medical devices) regulations 2002. the guideliner catheter has not undergone the more rigorous pre-market conformity assessment procedure relevant to a class iii device to provide assurance of its quality, safety and performance. in particular, the tga has not been provided with appropriate data on the design verification and validation of the device necessary for a class iii classification.
Acción
Pyramed is asking customers to identify and quarantine the Guideliner Catheter stock and advising that it cannot be used other than in accordance with the specific conditions attached to the Special Access Scheme (SAS).
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 confirmed analytical sensitivity values greater than 0.3mlu/ml described in the instructions for use when evaluating multiple lots of the advia centaur fsh assay and calibrator b on the advia centaur and advia centaur xp system.
Acción
Siemens is providing work around instructions for users to follow.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Beckman coulter has confirmed that the stability, while frozen, for the access folate calibrators may produce falsely elevated results which could mask a folate deficiency. product number a14207 may experience this issue at 12 months, and product number a98033 at 6 months.
Acción
Discontinue and discard remaining inventory. Review the historical quality control data and confirm Access Folate assay performance when using the affected lots in within the laboratory specifications.
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
There is a potential that the analyte comments may be deleted if the specific analyte is not counted in the mask. this risk is avoided in the case that the user makes comments against the “blood film comments” analyte for reporting blood film comments. the differential keyboard orders a profile that contains all of the additional blood cell types that can be manually counted. in many instances these additional cell types will not be identified in the count and will not receive a result (eg blasts, myelocytes, etc). the expected behaviour is that if a cell is not counted, then these analytes will be removed from the profile when the final count is accepted.
Acción
Roche is providing work around instructions until a software upgrade can be implemented to permanently fix the 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
There is a potential for incorrect handling of extra-long result messages that are sent form the cobas® 8000 data manager and received into it 3000 using a “v2” instrument driver. this is applicable for messages that are greater than 33 results in length per episode and if the configuration of the predefined buffer size is not optimal. the “v2” instrument drivers for cobas® 8000 use a buffer to ensure that extra-long result messages are processed correctly. if this buffer is not configured for the specific driver that is installed, then there can be a mismatch in the amount of data that is truncated. the effect of this being that results and flags after result #33 in the string may be delayed and in some cases may not be reported to cobas® it 3000.
Acción
Roche are providing work around instructions until a software upgrade can be implemented to permanently fix the 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
This is an update to the 'hazard alert' letter dated 24 may 2011, pertaining to the eon mini model 3788 and brio model 6788 implantable pulse generators (ipgs) inner battery cracking issues. st. jude medical received reports eon mini and brio ipgs that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant.
Acción
St Jude is providing information to implant / treating clinicians on how to manage the patients affected with this issue. For more information, please refer to the TGA Website http://www.tga.gov.au/safety/alerts-device-ipg-120924.htm
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 forceps inside the packaging may be the incorrect configuration. specifically, the outer packaging indicates the product is dbf-2.4sn-230-s (has non-spiked forceps head), but the forceps inside are actually dbf-2.4sl-230sp-s (has spiked large forceps head).
Acción
Quarantine and return affected devices to Cook Medical.
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
Three issues requiring correction have been identified by the manufacturer:1. during reliability tests on the steel rope, one of the springs broke and the safety catch did not hold. the safety catch mechanism does not activate due to the counteracting force of the remaining spring. as a consequence the u-arm moves down uncontrolled. the manufacturer has identified that this can occur in the field earliest after 2.5 years of operation. these 2.5 years are calculated for a worst case usage of the system. 2. during installation all 3 screws for one sib chain wheel were found loose. if all 3 screws of one of these wheels loosen completely, the detector carriage and/or the tube carriage can move down uncontrolled until stopped by the corresponding end stop.3. during in-house testing it was detected that the life time of the wire rope is significantly lower than the specified 10 years. the replacement of the wire rope every 3 years is required.
Acción
Philips is urging customers to contact them if they have any concerns and is replacing the vertical carriage, wire rope, SID chain wheels and Instructions for Use.
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
Alaris pump module model 8100 that contains the door assembly with keypad part number tc10005926 may be at risk of the door keypad overlap separating from the keypad assembly. when the pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm.
Acción
The sponsor is providing work around instructions to mitigate the risk and will be replacing affected units.