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
Maquet/getinge has received a complaint involving a cs300 iabp that did not pump due to an electrical test failure code #58 (power up vent tests fail) maintenance code #3 and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy. an electrical test failure code #58 is caused by a solenoid valve requiring more power than the solenoid driver board can deliver to open the valve. the lack of power prevents the coil from moving the plunger causing the valve not to open. this is recognized by the system as an electrical test failure code #58 upon powering on the iab. units distributed after december 11 2013 are not affected by the field correction.
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 received a higher than expected number of complaints regarding incomplete stent deployments with specific sizes and lots of pulsar-18 peripheral self-expanding nitinol stent 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
Manufacturer has received reports of lithium diode batteries having a potential to malfunction due to battery cell rupture which could cause user and patient injury and repair before can be used.
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 certain lots of cannulae to become damaged when the cannulae are not coorectly placed in single-site port.
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 have been reports that some electrodes in these lots may exhibit a separation of the sensing element from the body of the electr causing the electrode not to function. no injuries occur.
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
Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. the reported incidence rate requiring medical assistance related to thisissue is less than 1 in every 2 million infusion sets. over-delivery of insulin can cause hypoglycemia and in extreme cases death. medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. manufacturer investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. a membrane blocked by fluid may occur if insulin alcohol or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. infusion sets currently being shipped by medtronic contain a new and enhanced membrane material that significantly reduces this risk.
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
Incorrect name on the end panels of the carton of some lots of kodak ultra-speed dental film item 122 8840 (size 0 single film packet) df54. on the cartons where this error appears the word "insight" is incorrectly printed instead of "ultra-speed". the product inside the carton is true kodak ultra-speed film and all other labeling on the package is correct. the only error is the use of the word "insight" instead of "ultra-speed" on the end panels.
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 micro-electrode may continue to advance even when the remote control knob is released.
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 determined that the lots may not meet the analytical sensitivity) limit of dtection) of 10 colony forming units as decribed in the product insert.
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 an open peel test it was identified that the seals for a reaming rod sealed in packaging aids corporation jaw sealer machine had gaps/channeling in the seals therefore resulting in the potential for non-sterile product. recall initiated due to potential gaps/channeling in the seal of the package.
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
As part of regular post market surveillance activities siemens discovered an error in the 19" live display such that image reproduction may fail in the examination room. the loss of image can only occur immediately after system startup. this failure does not occur during normal operation or when the live image is displayed. only systems which use a live display (reference dshc1914-dc with part number 10656055) in the examination room are affected. live displays with other part numbers are not affected by this 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
It was identified that an incorrect magnesium cal 2 calibrator value (cal 2) was provided for one lot. the value is labeled as 3.2 meq/l but should be 3.7 meq/l.
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 main issue for the product is that it was not calibrated properly and may give inaccurate temperature readings. as such a person using this may not realize the severity of a temperature. we were informed of this issue as a result of a recall in the united states.
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
Gas module for no has the potential to fail premeturly.
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 received complaints which allege that a caster has broken on the top of the caster stem where the brake rod inserts into the caster. if more than one caster on a unit is damaged brake functions may be affected and result in reduced brake holding force. if only one caster on the bed is damaged brake functionality continues to meet specifications.
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
Product has not received market authorization for sale 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
Stryker instruments has received reports of casters failing in the field. the caster failures have resulted from the "swivel head of the caster which is a double ball bearing composed of polyamide that loosens over time" creating excessive swivel play. the resultant swivel play allows the caster to bind/jam with the chassis of the rover when force is applied by the operator to move 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
Products contain dry natural rubber material were not labelled with appropriate caution statement.
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
Issues relating to blood leackage and air introduction into the evacuated tube during the drawing process.
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
Software error that lead to incorrect factor transmitted to the gammamed and the computer used the wrong factor to calculate the treatment time.