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
Siemens healthcare has received a number of reports of gas cartridges failing to install on the rapidlab 348 and rapidlab 348ex instruments due to defective threads on the gas cartridges. the issue is intermittent and not all gas cartridges are affected.
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 revision or correction to a new medication order in the drug dosage screen makes the appropriate change in that screen but the change is not reflected in the medication snapshot display.
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 internal testing it has been determined that certain lots of argyle suction catheters may have pinholes in the packaging potentially compromising sterility 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
Following the initiation of a recall in june 2007 replacement boards had been shipped and later was discovered that the boards had been inadequately packaged resulting in damage during shipping.
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
Zimmer gmbh is conducting a medical device field action (removal) for flexible shaft (part number: 75.80.04). this instrument is part of an outdated technology. consequently there is a potential that this instrument may not be adequately cleaned when using the standard cleaning 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
An anomaly has been identified with the ct localization module of the fastplan treatment planning system. if the module reports a significant different in tilt or spin on a slice (compared to the average of all slices) and the user elects to "discard" that slice an incorrect calculation of the isocenter location may result. the calculated ct localization volume can be incorrect when the "discard option is selected after a detection of a significant difference in tilt or spin for a particular slice. if this issue goes undetected the reported coordinates of the isocenter will be incorrect and a mistreatment could result.
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 top panel was melted above the power jack due to the display pc board shorting to the case.
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
Control set has been reduced from 24 hours to 8 hours at room temperature from 30 daysto 7 days refrigerated and from 3 months to 2 weeks when frozen.
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
Over time very small aluminu or rubber particles may enter the regulator resulting in a partial blockage of the regulator. this may result in a faulty monitor calibration resulting in incorrect high gas reading.
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 current access and dxi instrument manuals specify an unrestricted ambient operating temperature range of 18*c to 32*c. some access immunoassays are affected by ambient temperature changes and can produce inaccurate results when a system is operated within the published range.
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
Sternum saw collet nut may not always allow for an easy insertion of the saw blade into the handpiece. they are used on conmed linvatec hall versipower and versipower plus handpieces or sold individually.
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 small number of masks have been labelled and sold as quattro air ffm med - amer which actually contain nv quattro air ffm large masks.
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
Teleflex is conducting a voluntary recall for certain lots of teleflex sutures because they did not meet minimum needle attachement strength requirements. if affected product is used the needle may become detached from the suture 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
Reported problems that the catheter breaks about one inch from the tip.
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
If the fluid warmer is powered off in an active alarm state the air detector/clamp will open and the air detector will become disabled.This could could allow the air to be delivered to the 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
In a specific workflow where contours are edited and then the contour is deleted on some slices and saved in the same session it is possible that the deleted contours are still present which would not be the intent of the planner. if the patient is not saved and recalled in a subsequently created plan the bev will show the contours as still present while the transverse sagittal and coronal views will show the contours as deleted. the total volume of the structure reported in the dvh and the structure control will not match. if the study set is saved and reopened before plan creation the total volume of the structure reported in the dvh and the structure control will be corrected. a similar workflow could trigger the defect if contour deletions and edits are performed while a plan is loaded.
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
Advanced sterilization products (asp) has determined that the sterrad 50 sterrad 100s sterrad nx as well as sterrad 100nx sterilization systems (the latter previously reported as affected in march 2013) may emit an odor or smell into the surrounding environment that is not typical of normal operating conditions.
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
Primer mix pm169a contained in the named kits may produce a weak true positive band at the correct base pair size of 135bp. the primer mix is designed to detect b*15 alleles. the problem of a weak true positive signal could mean that a test would have to be repeated.
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 determined that calibrator values (data/calibration mathematics) for vitros fs calibrator 1 lot 91461 are not available for selection on the assay data diskettes drvs 5904 through 5910. vitros fs calibrator 1 is used on vitros systems to calibrate the following assays: vitros amph aso barb benz cocm d%a1c dldl hscrp pcp rf and thc reagents.
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
Devices manufactured with 6 inch threaded casters require annual inspection. the devices are being sold as used equipment and may therefore no longer be serviced by draeger trained personnel.
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 original results were modified or deleted in function meh original/unmodified results were saved to file and released upon inquiry. dk.