The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
In 2017, the following incident involving a hase bikes trailer kit was reported to us: a child seated in a trike that was being pulled as a trailer took their hands off the handlebars and touched one of the brake discs, injuring themselves.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
In extremely rare circumstances, the algorithm for the cobas® hiv-1 and hbv tests for use on the cobas® 4800 system may inappropriately call an extraordinarily high viral load sample as negative (i.E., false negative result).
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
Pentax medical has identified an error in the description of the operating instructions of the pentax ultrasone video bronchoscope eb-1970uk.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
In collaboration with the european regulatory agencies (competent authorities and our notified body) and medical experts, abbott vascular is in the process of collecting additional evidence from clinical practice for the absorb bioresorbable vascular scaffold (bvs) and absorb gt1 bvs systems. on the european market. from 31 may 2017, the absorb bvs will only be available for use in the context of clinical registers in specific centers / institutions, which will play a key role in the monitoring of this technology until the summer of 2018. at that moment the situation will be reassessed. to become.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
We have observed that false errors 0522 “air detected: aspiration during protocol” occurred randomly when performing the vidas lyme igg (lygs) parameter or protocol (cerebrospinal fluid) on vidas®3 systems for a specific reagent batch.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
Siemens healthcare diagnostics has confirmed that the immulite 2000®/immulite 2000 xpi® sex hormone binding globulin (shbg) adjustor lots 124 and 125 packed with reagent lots listed in table 1 do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8°c, as published in the instructions for use (ifu).
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
Customers have reported that, on rare occasion, the devon™ light glove may split upon application to the devon™ light handle adapter.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
We have discovered that a recent delivery of scholl solution for fungulas / solution mycoses from ongles to your warehouse may contain products whose labeling and instructions for use are only in french.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
Carefusion has identified a risk with the alaris pk plus syringe pump that resulted in a situation where the near end of infusion (neoi) audible alarm on the 8005tig01 pk syringe pumps was not heard and/or not recognised by the clinician.
the issue is isolated to the product code 8005tig01 only.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
The products in question are not provided with the correct labeling as required by european legislation and may therefore no longer be available on the european market.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
A v60 breathing device with software version 2.20 installed can mistakenly detect that the fan motor is stalled. if this condition occurs, the software will shut down the ventilator (vent inop) and display error code 100e.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
We would like to draw your attention to the fact that the küschall wheelchairs produced between 12 october and 20 december 2016 have labels that are not in accordance with our quality standard.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
This field safety corrective action (fsca) is being conducted following customer reports of the valleylab laparascopic handset continuing to operate after release of the activation button.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
We regret to inform you that in case the elecsys pth (1-84) assay lot 185522 (expiry date may 2016) and elecsys tsh assay lot 185522 (expiry date june-2017) were ever used on the same cobas 8000 modular analyzer series configuration (which includes cobas e 602 module), this will lead to the following consequences to the tsh (see attachment).
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
This safety measure ( field safety corrective action, fsca ) is carried out due to an error in the labeling.
the label indicates that the product does not contain latex, but the headband part that comes with the forehead sensor does contain latex.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
Through customer feedback we received information that the level of intensity of the shock wave application has increased unintended during treatment.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
The purpose of this formal notification is to inform you about the discontinuation of the flextherm heater cooler sales and distribution activities and the voluntary removal of all devices installed at customer sites.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
A v60 breathing device with software version 2.20 installed can mistakenly detect that the fan motor is stalled. if this condition occurs, the software will shut down the ventilator (vent inop) and display error code 100e.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
There have been reports of instrument malfunctions for phadia 250 due to deformed bottles in the below mentioned products and lots.
the deformation of the bottle can cause an erroneous volume detection by the instrument which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
We have provided these instructions due to a procedure where a patient experienced three episodes of ventricular tachyarrhythmia‐ one related to initial guidewire placement in the ventricle and two related to use of the helical infusion catheter with the morph guide during positioning within the left ventricle.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
Bd proceeds to a spontaneous corrective safety action for all shoots of bd plastipak spray 100 ml, catheter tip (ct), with an expiry date of 5 years. the syringes are taken back due to leaks along a stopper during internal real-time routine stability tests. this defect would arise from 2 years after the date of manufacture.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
Smith & nephew has established that a number of consoles of the versajet ii system contain a component whose lead content (pb) may exceed the limit laid down in the rohs directive.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
Verathon inc. has become aware that product labelled as gvl® size 2 stat lot gc32825 was physically packaged with gvl® size 1 stats.
as a result, patients for intubation with a gvl® size 2 stat may inadvertently be intubated with a smaller gvl® size 1 stat.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
Notas adicionales en la data
Causa
Complaints from customers about control ci (lot 10184751). reports have been made of produced results that are outside the acceptable margin given in the package leaflet. the component in question is packaged with the four aforementioned alere afinion ™ lipid panel control lottery tickets. a cloudy appearance and unpleasant odor were also reported.