Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Complaints of auto-agglutination with the test latex reagent and false positive results noted with the negative control strain-staphyloccus epidermidis#12228.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Bd has confirmed a limited number of tubes associated with the lots listed and currently in the market may exhibit stopper pullout where the stopper is withdrawn from the tube as the user removes the needle from the stopper following specimen collection.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Complaints received for distal tip breakage of the synfix lr low profile u-joint driver with instances of the tips remaining in the patients.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Immediately after creating a setup field in rt chart version 7.3.10 the focus reverts to the treatment field. varian has received reports that users have sometimes failed to notice this focus and have proceeded to delete mlc and other accessory components from the field in the mistaken belief they were acting on the setup field.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
In may 2013 smiths medical received a complaint concerning a medfusion 4000 pump with thermal damage to the ac receptacle as a result of an electrical short. an in-depth investigation performed by a third-party laboratory concluded that an electrical short can occur when saline solution or other conductive fluids (ie. potassium chloride) enter the pump's ac power receptacle. when this happends sparking and/or flames accompanied by smoke may appear at the power receptacle. the pump and ac power cord are constructed of flame retardant materials therefore the sparks/flames extinguish within seconds.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Certain lots of ceramic femoral heads have been found to spontaneously rupture. the manufacturer of the ceramic heads changed the manufacturing processes in 1998.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Orhto clinical diagnostics has received customer complaints of intermittent imprecision outliers or shifts in control fluid values when using various lots of vitros chemistry products phbr slides (phenobarbital) from coating 0053. the investigation confirmed that biased values for patient samples could be obtained that may or may not be detected by quality control fluids.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Through post market surveillance data review edwards lifesciences has identified specific lots of the endoreturn arterial cannula that were built with an incorrect component. this component can create a performance problem with the intraclude intraaortic occlusion device.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Review of test records indicated that the seven impacted powerhart g3 aeds manufactured by cardiac science corporation (csc) may not have received adequate testing prior to being shipped from the factory.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
1) possible impact of significant vibration or jarring to omnifuse pumps: due to sensitivities of the precision accuracy detection mechanisms within omnifuse pumps certain levels of vibration or jarring during transport can induce a system fault code. 2) affect on the totaliser display after resetting the pump to clear a system fault: if a system fault code occurs during an infusion and the pump is reset the totaliser display will not include the most recent infusion data.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
When the primary protective barrier was removed out of the path of the fluoroscopic x-ray beam x-ray exposures were not inhibited as required by 21 cfr 102032(a).
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
It was detected in qc control that the hole used to thread the solis trial onto the implant holder was manufactured on the left side of the instrument instead of the right as indicated on the engineering print. this leads to the trial being placed upside down on the handle. the implant handle has markings indicating the cranial and caudal sides on the top and bottom respectively. the nonconforming trials result in the cranial side of the trial being inserted facing caudal.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Novo nordisk a/s has detected that the insulin cartridge holder used in a select number of novopen echo and novopen 5 lots may crack or break if exposed to certain chemicals for example certain cleaning agents. novopen echo and novopen 5 are used for insulin treatment by people living with diabetes. novopen 4 and flextouch are not impacted.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
During examination if the patient is positioned with his knees pointed to the rear of the system and the operator performs a wrong movement of the scanning beam downwards instead of upwards the leg(s) of the patient might collide with the stand and get squeezed potentially resulting in a (serious) injury.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Software errors including possible hangups and data loss.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
A multi-sipping issue was found in bd multiset software version 3.0.1 the sw is not adjusting its acquisition criteria for some samples. it only displays the last batch of events acquired.
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
Notas adicionales en la data
Causa
Information regarding cyanokit interference on billirubin test results was missing in bilt3 instructions for use.