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
***see 33-02 as description does not fit in the space provided***.
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
Siemens healthcare diagnostics has confirmed low frequency of barcode read errors with the dimension vista tobr flex reagent cartridge lot 13095ab and dimension vista crbm flex reagent cartridge lot 13095ac. if the impacted flex reagent cartridge cannot be read the instrument will post a "bad barcode" error on the instrument screen. the impacted flex reagent cartridge will not be loaded on the dimension vista.
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
Edwards lifesciences has identified a potential safety risk which may occur during the use of the intraclude intra-aortic occlusion device (icf100) used in cardiopulmonary bypass surgery. edwards has received a limited number of reports regarding device damage on the strain relief near the hub area. some of the reports have also indicated blood leakage in this area. when damage exists blood loss can occur because blood can fill the device between the lumen shaft and the strain rerlief and leak from the area. no injuries or blood transfusions have been reported. in a worst case scenario with no mitigation blood loss can occur during use of the 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
Intubation hoops utilized in the manufacture of the hr-im intubation head ring assembly have been produced with excess material beyond the pivot drill hole. when pivoting the intubation hoop into the down position this excess material can come in contact with mating accessories making it impossible to (a) pivot the hoop into its final downward position or (b) prevent the accessories from being fully seated into the head ring assembly.
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
Stryker was aware that the revision rates associated with the eius knee system were higher than other similar devices.
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
Alkaline phosphatase has been reported to contain visible mold inside multiple r2 cartridges. in-house visible observation of customer returns and in-house r2 reagents found visible matter inside multiple r2 cartridges. in-house testing was performed the lot failed to calibrate/generate results and failed to meet the following specifications: microbial contamination of less than 30 cfu the reagent being free of foreign matter and performance criteria by a failure to calibrate or generate results with an active calibration.
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
Potential for a distal section of the catheter to degrade following exposure to uv (i.E. sunlight) or fluorescent (i.E. office) light and reminded users to store the device in a cool dry dark area.
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
Siemens has conducted an internal investigation of calibration failures due to slope errors that are not resolved with routine maintenance. a low frequency occurrence of this issue has been confirmed for certain stratus cs testpak lots as they approach their expiration date.
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
Weld between the post body and the screw was not properly formed and may fail even when minimal force is used which could result in the screw having to be removed from the bone by other means.
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
Wrist band fiber particulate was identified on the sealing surface inside the valve. preventing a complete seal of the inflation valve resulting in a slow balloon air leak.
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 detailed investigation points to a unique use case involving a single canadian customer using non-approved smiths medical pouches with the cadd? blue-striped administration set. use of non-approved accessories as indicated in labeling may adversely affect pump operation. smiths medical has decided to proceed with sending communication to notify all canadian customers who have purchased the cadd blue-striped administration set. the content of the fsn provides more information to the customer / user when using the administration set. fsn emphasizes the correct use of the product and how to avoid strain relief which in turn prevents leakage.
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
Smiths medical reports the intermittent occurrence of binding of the locking assembly on some cadd-solis pumps. binding on the cassette/keypad lock can occur after latching the cadd-solis medication cassette reservoir or administration set disposable to the pump. when binding occurs it can prevent the key from fully rotating the cassette/keypad lock to the locked (engaged) position. to start an infusion with pump models 2111 and 2112 and model 2120 when in pca mode the lock must be fully engaged. this issue is limited to specific serial numbers only (1061043 through 1067598).
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
Anomaly regarding correct wedge orientation for 20 cm wide 30-degree upper wedges.
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
There is a tabulation error in the integrated data management system (idms) software product code 464100 versions 7.1 through 7.3 used with the hemochron response instrument that affects the operator and the device performance summary reports for two electronic quality control (eqc) tests.
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
This issue concerns an issue with the evaluation of biological clinical goals in raystation 3.0. raystation 3.5 raystation 4.0 raystation 4.5 raystation 4.7 and raystation 5. biological clinical goals for an adapted plan based on another planning ct than the original planning ct will show incorrect values.
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
Ct import into focal with subsequent plan import into xio may lead to incorrect isocenter location. may occur if the dicom ct data is imported using focal and the dicom rt plan is imported via xio.
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
The frax software tool associated with some discovery w and discovery wi qdr series bone densitometer systems is being recalled because it is not approved for distribution in 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
Ethicon is conducting a voluntary product recall of all lots of gynecare morcellex tissue morcellator due to the potential for the duckbill seal to become dislodged and a confirmed event in which the seal was retained in a patient.
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
Since launching the persona knee system zimmer has received complaints related to the fracture of tibial articular surface provisional (tasp) tops and bottoms with a complaint rate of approximately 0.82%. zimmer determined that updates to device labelling were required to provide additional clarification to the instructions for use of the tasp construct.
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
Reduced battery performance (estimated at 2.1% of affected population) has resulted in 8 occurrences of low battery reset between 47 and 56 months and 1 occurrence of premature elective replacement indicator (eri) at 54 months post-implant. for affected pumps the minimum timeframe of 90 days between eri and end of service (eos) may also be reduced.
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
Potential limit switch failure could occur due to collision between lateral plane of innova positioner & other equipment which may break x-ray & positioning switches & may not allow exam completion.
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
The default pulse rate may be set to 25/30 pulses per second (pps) which may result in a dose rate in excess of 20r/min.
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
The two plates were mixed up during the manufacturing process and may be mislabeled with the wrong identifier.