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
For 10-20-30ml heparin syringe carrier:new instructions on how to correctly load syringe in new heparin syringe carrier.If not followed a risk of negative pressure exist with the potential for overdelivery.
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
Manufacturer identified a number of translational discrepancies between the 2020 french user guide and 2020 pump. none of these discrepancies have an impact on treatment.
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
Terumo cardiovascular systems (terumo cvs) has become aware of a remote possibility that terumo advanced perfusion system 1 could experience a spontaneous loss of power. terumo cvs is issuing this advisory because the user's manual for the terumo advanced perfusion system 1 does not provide user instruction for responding to such an event.
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
Carestream has identified an issue related to the drx-revolution mobile x-ray system where the boom arm can become loose. it has been determined that this issue is a result of an improperly assembled part which holds the x-ray tube assembly/boom to the device mounting block at the top of the column.
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
Beckman coulter has received reports of increased recovery of control and patient samples using the lots of immage buf1(with immage immunochemistry system).
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 cusa excel family of ultrasonic tissue ablators are used in surgical procedures where fragmentation emulsification and aspiration of soft and hard tissue is desirable. the excel family of devices is tested against standard 60601 for electrical safety fire and mechanical hazard compliance by underwriters laboratory (ul) against european standard ul and canadian requirements. however the three excel consoles that have been imported and distributed in canada do not have the required specific ul canada logo.
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
Possible failure of the factor v leiden control template (positive control) included in the factor v leiden kit for use with the lightcycle 2.0 instrument.The factor v leiden control template may fail to meet the validity criteria set by the macro component of the lightcycler 2.0 instrument.
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
Synthes (canada) ltd. is initiating a voluntary recall to remove the 4.5mm curved condylar plate. this recall is being initiated as the straight condylar plate is etched with a curved condylar plate part number. the potential hazard is a possibility of a delayed surgical procedure. synthes has not received any reports of adverse events associated with the use of the 4.5mm lcp curved condylar plate subject to this notice.
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
Possibility that some units of this manufacturing lot included the wrong instructions for use document.
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 may be circumstances where the brake holding force may deteriorate over time.
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 first broach 1 point hex of the implant had a shallow dept compared to the required dimension on the drawing for the implant.
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 carbapenemase producing enterobacteriacae (cre) reported false susceptible with the carbapenem imipenem. the instrument rapid read (<16 hours) reported imipenem of <4 ?g/ml on a synergies plus negative panel and after overnight incubation imipenem was resistant (>8) by visual examination. this results in a categorical very major error (vme).
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 review of the ifu it was detected additional missing contraindications and reprocessing instructions also required revision. there is no clinical data linked to the usage of the ds clips for the closure of the renal artery or renal vein during nephrectomies in living donor patients aesculap wants to avoid any potential patient risk by including this and other missing contraindications and also revising the cleaning and sterilization instructions.
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
Blister pouches were found punctured during production.
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
Manufacturer has confirmed that dimension vista calcium (ca) flex reagent cartridge lot 16060bb may produce erroneously low results from specific well sets. this issue occurs infrequently affecting less than 1 per 350 wells (< 0.3%). if calibration is performed using an unaffected well set and samples are subsequently run using an affected well set ca results may be falsely depressed up to -2.9 mg/dl [-0.72 mmol/l]. if qc is run using an affected well set qc may detect the issue.
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
Ground pin of the ac power plug may become loose or break off causing the grounding of the unit to be compromised.
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
Ortho clinical diagnostics has received customer complaints concerning intermittent immuno-rate wash condition codes imprecision outliers or shifts in control fluid values when using vitros phyt slides from coating number 0115 only.
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
Fda inspection of pump manufacturing facility found manufacturing processes not in compliance with regulations - reliability of devices cannot be assured which could result in over or under infustion of insulin.
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 sustainability solutions has received an increase in reports indicating that the reprocessed h12lp trocar adjustable plug may break in the packaging or during use.
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
Improper latching mechanism may allow collimeter to disengage during camera use.
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
Failure to actuate (open) some reagent packs. the following can result in probe crashes if not detected: separation of the flipper bar from the caps caps that do not remain open and broken cap hinges.
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 the actuator to fail resulting in the possibility of the patient to be dropped.
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
Result mix up that can occur when sample ids (barcode number/tube identifier) are repeated in the psm database and results are manually resent to the hospital host system (laboratory information system (lis)).
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 affected blankets are more susceptible to unintended occlusion of airflow resulting in partial or limited inflation during use. if blankets are only partially inflated during use in surgery there is potential for incomplete warming therapy to be given to a patient.