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.
Notes supplémentaires dans les données
Cause
While creating or modifying a report using microsoft word application in classic client, when content is pasted from an external source including the formatting ‘section break’ or by inserting it manually, data from the pre-defined sections (e.G. report, diagnosis) of the template might not be saved to the syngo workflow mlr database.
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.
Notes supplémentaires dans les données
Cause
Zimmer biomet was inforrned through complaints of certain cement powder being too compact and/or showing an increase in the intended polymerization time involving certain batches of optipac@ refobacin@ revision.
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.
Notes supplémentaires dans les données
Cause
As a result of a potential leaking of the coolant couplings of the flat panel detector, liquid may escape above the flat panel detector in the fd carriage. this leaking can occur sporadically on axiom artis systems from the production patch affected.
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.
Notes supplémentaires dans les données
Cause
This letter contains important programming information to prevent unintended asynchronous biventricular (biv) pacing behavior during tracking of increased intrinsic atrial rhythms in certain boston scientific cardiac resynchronization therapy pacemakers (crt-ps) and defibrillators (crt-ds).
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.
Notes supplémentaires dans les données
Cause
In these cases, users misinterpreted still images on philips' x-ray systems as live images.
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.
Notes supplémentaires dans les données
Cause
Boston scientific has received reports on intermittent oversensing of the minute ventilation (mv) sensor signal in certain pacemakers and cardiac pacemakers (pacemakers) for boston scientific cardiac resynchronization therapy.
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.
Notes supplémentaires dans les données
Cause
Baxter healthcare corporation is issuing a voluntary product recall of hd conventional lines with product codes and lot numbers mentioned above due to customer complaints received for breakage of the pre-dialyzer arterial expansion chamber during different treatment phases.
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.
Notes supplémentaires dans les données
Cause
As of october 2017 z-index omitted the interaction severity level from the g-standard database and therefore the mim can’t alert users when interactions occurs.
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.
Notes supplémentaires dans les données
Cause
Ventana medical systems, inc. (ventana, also known as roche tissue diagnostics) has received increased customer complaints reporting leaking and sticking reagent dispensers. these reports are currently focused on horseradish peroxidase (hrp) dispensers (part of the iview, ultraview and optiview detection kits, as well as cintec plus cytology kit) and with hematoxylin ii.
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.
Notes supplémentaires dans les données
Cause
The gas test results showed that the emission of formaldehyde exceeded the threshold values set by the netherlands.
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.
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.
Notes supplémentaires dans les données
Cause
We issue this notification after receiving notifications that the signia ™ feeding handle may unexpectedly fail during use.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.
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.
Notes supplémentaires dans les données
Cause
After analysis, it has been found that the roller system that controls the infusion rate is sometimes partially removed from its slot, causing it to lose its normal functioning.
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.
Notes supplémentaires dans les données
Cause
Merit medical has received complaints indicating that the wings of certain parties of the prelude snap have been demolished during the splitting of the hulshub.
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.
Notes supplémentaires dans les données
Cause
An internal investigation has shown that the sleeve of the working channel may not be sufficiently attached to the inside of these tools. this may cause the sheath of the working channel to protrude from the camera cap at the distal tip of the catheter.
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.
Notes supplémentaires dans les données
Cause
Establishment labs is initiating this voluntary field safety notice (fsn) to inform of a change in the directions for use of the aforementioned products.
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.
Notes supplémentaires dans les données
Cause
With this notification we would like to inform you about the possible sample mismatch within one rack.
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.
Notes supplémentaires dans les données
Cause
In some cases, adult standard sized peritoneal dialysis catheters were placed incorrectly in pediatric peritoneal dialysis catheter packages.
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.
Notes supplémentaires dans les données
Cause
A manufacturing fault has been identified with the intersurgical bvm manual resuscitation system, which could result in the directional valves positioned on the ‘back plate’ of the selfinflating bag being orientated incorrectly.
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.
Notes supplémentaires dans les données
Cause
In case the error occurs, the foot control might not switch back to zero position when the pedal is released.
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.
Notes supplémentaires dans les données
Cause
It has been brought to our attention that customers have supplied a small number of patterson walking frames (both with and without wheels) with the pins of the clamping springs broken into the adjustable legs.
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.
Notes supplémentaires dans les données
Cause
Probes standard settings in elaxto mode (elastosonography application) were not correct for certain probes as described below in section 2, which can result in overheating of the probe head.
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.
Notes supplémentaires dans les données
Cause
Sybron endo received a recent increase in complaints relating to overheating buchanan heat pluggers only while used with the elements obturation unit (eou) and not with other systems such as elements free or system b.
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.
Notes supplémentaires dans les données
Cause
Our regulatory reporting process has shown that the labeling of the legacy1 sbm implant assembly may not meet the specification because this product has been given an incorrect batch number.