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 lps lower extremity dovetail intercalary component has the potential for the female component to fracture when exposed to certain physiological loads.
Acción
Johnson & Johnson Medical is not recommending prophylactic treatment in the absence of symptoms. Surgeons are recommended to review each patient’s case to determine the best treatment options, considering the patient’s weight, activity level and/or any other potential contributing factors.
If a patient presents with a fractured LPS Lower Extremity Dovetail Intercalary component with well-fixed proximal and distal stems and the surgeon determines that the LPS Lower Extremity Dovetail Intercalary component is the best treatment option, the company will make the LPS Lower Extremity Dovetail Intercalary component available. For more details, please see http://www.tga.gov.au/safety/alerts-device-limb-preservation-system-130805.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
Atrium medical has become aware that the label on the tab of the inner tyvek cover can adhere, to the inside wall of the outer tray. this may make it more difficult to employ the user's current technique which is to first pass the inner tray from the outer tray and then onto the sterile field. in some cases, because of the sticking of the inner tray to the outer tray, it has been reported that the inner tray must be lifted from the outer tray.
Acción
Atrium medical are advising users of work around instructions to follow to prevent the issue from occurring.
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
Livingstone international would like to advise that batch number t09ak of sterile disposable syringe 3ml - luer slip may not be sterile.
Acción
Livingstone International is requesting users to quarantine and return any affected 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.
Notas adicionales en la data
Causa
Baxter anz received feedback from a customer that an iv tube could not be loaded into an infusion pump because the slide clamp was not correctly assembled. baxter facility received the complaint sample and confirmed the slide clamp had been assembled in the reverse direction. the incorrect assembly would lead to incorrect direction of infusion such that blood may be withdrawn from a patient and result in acute blood loss and/or delay in treatment of life sustaining medication as a worse case scenario.
Acción
Baxter Healthcare are advising customers to remove affected product from use and return to Baxter 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
The ct system phantom supplied with the affected scanners has a special pin by which the customer can check the low contrast (lc) detectability for quality assurance. this pin consists of a nylon (aculon) body with six smaller lexan pins of 3mm, 4mm, 5mm, 6mm, 7mm and 8mm diameters, which have contrast difference of approximately 1% from aculon.The lc test is performed by visually inspecting the section and selecting the smallest detectable lexan pin for a predefined scan protocol as defined in the instructions for use (ifu) manual. this manufacturer-recommended procedure is subjective in nature and needs to be performed on several scans and by different people to be reliable.This pin visibility deteriorates over time because of slow water absorption. as the pin visibility deteriorates, the test becomes unreliable and inaccurate.
Acción
The customer letter is providing a guideline to a more reliable check of the image noise on the water layer of the system phantom to assure that LC is within the specification. The letter is an addendum to the Instructions for Use. It replaces the Image Quality Low Contrast measurement instructions found in the 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
Siemens healthcare diagnostics has confirmed an increase in the rate of abnormal assay errors (e143: abnormal assay) with the dimension vista rf flex reagent cartridge lot 12283ma. the errors can occur on calibration, qc and/or patient sample. any result produced with the abnormal assay error is deemed non-reportable as stated in the dimension vista operator's guide (section 5-49).
Acción
Siemens Healthcare is advising users to discontinue use and discard remaining inventory.
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
Atrium medical has become aware that if the product is exposed to excessive humidity for an extended period of time, the increased humidity occurring inside the pouch can potentially cause the coating on the mesh to strongly adhere to the inner handling sleeve. this becomes evident if:- it becomes difficult to peel the mesh from the handling sleeve, or- the yellow coating material separating the mesh is retained on the clear plastic liner.
Acción
Atrium Medical is providing users with updated Instructions for Use (IFU) which include an additional warning and handling information to ensure the device is not used if the coating material separates from the mesh. The storage requirements have also been added to the product labels.
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 an internal investigation, a formulation error was identified during the manufacture of the cobas 4800 hpv master mix reagent leading to an increased rate of invalid runs. this issue does not cause incorrect specimen results, however results from failed runs must be repeated.
Acción
Roche is requesting users to discontinue use and discard all units from the affected lots. Roche will replace any affected 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.
Notas adicionales en la data
Causa
Hemocue has become aware of a production related problem that affects some single pack pouches of certain lots of urine albumin microcuvettes, where the foil within the pouch has been damaged. if a single pack pouch is damaged, the microcuvettes can be exposed to moisture which in some cases may lead to high false readings.
Acción
HemoCue is asking users to discontinue use of the affected lots. Affected product will be replaced by HemoCue.
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 hypomon is not detecting hypoglycemic events at the required levels as indicated in the instructions for use (ifu).
Acción
AIMEDICS is requesting customers return the goods for a full refund of the purchase price. For more details, please see http://www.tga.gov.au/safety/alerts-device-hypomon-130805.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 manufacturer, ascension orthopedics, has received complaints of implant fractures that were observed post-operatively and required revision surgeries. most confirmed cases of implant breakage have occurred as a result of excessive loading and within a year of being implanted. excessive loads placed on the implant through high impact activities or sudden trauma can damage an artificial joint, particularly in the presence of poor bone stock. high impact activity may cause loosening or fracture of the implant. the breakage can result in glenohumeral joint pain and possible damage to the surrounding tissues.
Acción
The implanting surgeons are advised that the affected patients should be followed up in accordance to standard clinical practices with radiographic evaluation of the shoulder being conducted at each follow-up visit. LMT Surgical Pty Ltd is advising that future supply of the product in Australia will not occur before appropriate corrective actions are implemented. It is expected that this corrective action will take several months to complete. For more details, see http://www.tga.gov.au/safety/alerts-device-pyrotitan-130812.htm
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 investigations by arjohuntleigh it has been determined that the din connector used on these beds has been compromised during the cable manufacturing process. the supplier has determined that liquid droplets have been found inside the male din connector. this substance has been identified as phosphorous that is leaching from the black plastic flame reduction material used in the din connector. the effects of this can lead to a high resistance (ohm) connection between the pins and could result in the beds performing uncommanded movements.
Acción
Customers are requested to remove beds from use and contact the ArjoHuntleigh Service Line immediately if at any time a Contoura 380 or 480 bed performs uncommanded movement. An ArjoHuntleigh Technician will attend each facility to replace any defective DIN connectors. DIN Connectors with production batch date of October or November 2010 will need to be replaced. DIN Connectors with production batch date of January 2011 and February 2011 will undergo a Megger test which will determine if the connector needs to be replaced. This action has been closed-out on 19/05/2016.
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
Some affected packs of the compat ng tubes have been delivered in an insufficiently sealed pouch, thus compromising the sterility claimed on the label.
Acción
Nestle Health Service is asking users to quarantine affected lot numbers from use. Nestle will be replacing affected stock with a replacement 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
Dentsply has been advised that two lots (batches) of fluorocore 2+ fast set may exhibit faster setting characteristics than is normal for these products.
Acción
Dentsply is requesting users to request a Return Material Authorisation Number and return affected 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.
Notas adicionales en la data
Causa
When using 80kvp with intravenous contrast in head and neck studies with u-filters (ua, ub, uc), a vascular artefact that resembles thrombus may appear on the image. there is a risk of misdiagnosis which can lead to unnecessary treatment of a patient. for certain patient populations, this could contribute to serious injury.
Acción
When the settings (80 kVp with intravenous contrast in head and neck studies with U-filters (UA, UA and UC)) are used, Philips recommends performing additional reconstruction with a non-U filter and comparing the result images to verify no such artefact is evident. Customers are advised to continue to use 80 kVp with U-filters for brain perfusion scans. Refer to the Instructions for Use (IFU) for the selection of an arterial input unaffected by discontinuity should one occur.
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 rare cases the amulet mammography system may freeze during stereo/biopsy-movement in biopsy examination. once this failure occurs, continued system operation is impossible until a fujifilm technician corrects the issue.
Acción
FujiFilm is requesting users to discontinue use of the biopsy unit until the faulty components are replaced. Screening without use of the biopsy unit may still be performed in the interim.
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.