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.
Extra notes in the data
Reason
Low recovery values for lithium and soium heparin samples when using digoxin (dgn) with reagent lot numbers m102323 and m106240.
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.
Extra notes in the data
Reason
Default configuration may have been modified so that rejected images are included in the retrieved exam resulting in those images being displayed erroneously on external dicom 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.
Extra notes in the data
Reason
Sw update to correct signals during tube adjustment. this correction is a performance issue not related to patient or operator safety.
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.
Extra notes in the data
Reason
A component within the pressure switch which monitors for loss of drug supply may tear causing inomax to leak from the rear of the system. as a result the inomax cylinder empties more quickly than normal. an interruption or delay in the administration of inomax therapy may cause worsening of systemic oxygenation indices (i.E. hypoxemia especially manifested as decreased arterial oxygenation saturation) hypotension and/or increase in pulmonary arterial pressure.
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.
Extra notes in the data
Reason
A prepstain system rack setting was incorrectly entered (during a routine preventive maintenance visit) resulting in a tube position with the wrong y offset for rack four only. specifically the y offset had the 12th position mapped to an incorrect tube. the error consisted of a single patient sample being drawn and deposited on four (4) consecutive slides: - patient specimen from tube 1 was deposited on slides 1-4. - patient specimen from tube 5 was deposited on slides 5-8. - patient specimen from tube 9 was deposited on slides 9-12. the error was introduced due to an incorrect keystroke by the bd field service engineer (fse) (human error). the incorrect rack setting led to: - patient samples which were not tested during a test run (specifically each run of 48 patient samples would include 9 patient samples that were not processed) and - incorrect reporting of patient results. the 9 patient test results (not tested) were reported from the other patient specimens.
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.
Extra notes in the data
Reason
The calibration ring artifacts may be present on axial head scans that are performed with rotation times of 1.0 or 1.5 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.
Extra notes in the data
Reason
The 125ml centrifuge bowl component of the uvar xts xt125 photopheresis procedural kit may leak blood.
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.
Extra notes in the data
Reason
Obsolete pumps with system may have been removed and electrical cables left if cables not removed contact with starter fluid overflow may cause electrical short.
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.
Extra notes in the data
Reason
Pin of feeding adaptors may not be aligned which create a restriction within the adaptor preventing food from getting through the occlusion.
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.
Extra notes in the data
Reason
For clariview and screen save from gvtk (gems visualization toolkit) viewer the mr product can generate image headers with nonunique series identifiers which when exported to some pacs systems results in the series being associated with the incorrect study on the pacs. the intended study will not have the correct series listed and an unintended study will have it listed instead. in all cases patient identifying annotation remains correct. the issue may result in an incorrect diagnosis from the study with mixed patient data if the series protocol and anatomy on the studies are similar and the annotation is not noticed. the conditions under which the issue is known to be possible require that the studies have identical time of day (identical hours minutes and seconds) and that the exams be on an affected model of pacs at the same time. this is possible with one scanner on different days or on different scanners on the same day.
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.
Extra notes in the data
Reason
If static electricity is transferred to the level-sensor connector damage to the flow control module board may occur leading to instrument failure and inability to run stat hemoglobin specimens.
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.
Extra notes in the data
Reason
Product investigation and analysis concerning reports of the inability to communicate or recharge the eon mini ipg has identified weld cracks in the ipg's inner battery as the cause of this issue. there is a need to more frequently maintain and replace welding fixtures to assure complete alignment between the welding apparatus and the battery. there is no exposure of electrolyte material 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.
Extra notes in the data
Reason
Potential variations in values measured in the ref mode (refractive power) were reported with respect to the firmware included in rk-f2 full auto ref-keratometer. canon inc. has determined that there are potential variations in the optical system switching time between the alignment motor and measurement period and therefore fluctuations in measurement values may occur. canon inc. will resolve this potential issue by upgrading the firmware in the rk-f2 auto ref-keratometer.
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.
Extra notes in the data
Reason
Therakos recently became aware that some customers have experienced a higher rate of blood leaks than what is typical for this product. these leaks which occur between the centrifuge bowl and the drive tube may or may not be preceded by a system pressure alarm or a blood leak alarm and have been observed at various stages of 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.
Extra notes in the data
Reason
Some capacitors from specific lots may perform in a manner that leads to device malfunction including intermittent or permanent loss of therapy or premature battery depletion.
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.
Extra notes in the data
Reason
Manufacturer has identified a situation where the wbc result and the differential may be overestimated and not invalidated in this situation the wbc optical count may be identified as kinetic optical count.
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.
Extra notes in the data
Reason
The devices were stolen while en route to sterilization facility sometime between april 8 2011 and april 11 2011.
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.
Extra notes in the data
Reason
Manufacturer found one case (72 cartons) of promogran m772028 that contained some cartons of promogran pg004 lot 1336 mixed with the cartons of promogran m772028 lot 1336. m772028 is the item code for the canadian market. pg004 is the item code for the us market and as such is not licensed 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.
Extra notes in the data
Reason
La reactivite et la performance de l'amplichek swab ct/gc control amplified positive (controle positif pour neisseria gonorrhoeae) peuvent varier selon le lot mais surout selon les methodes d'analyses.
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.
Extra notes in the data
Reason
Grey shading on the test area that could lead to a higher than expected incidence of false reactive insti results.
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.
Extra notes in the data
Reason
The protective optic was reported to be loose and rattling around the inside of the 2p-esf body prior to installation of the opthalmic laser delivery device called easyfit slit lamp.
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.
Extra notes in the data
Reason
The stability of the specified lots of the kallestad anti-mpo (panca) microplate eia test kit has declined over time. the manufacturer has observed that the optical density (od) and value of arbitrary units of the positive control decreases over time eventually causing an invalid test.
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.
Extra notes in the data
Reason
Abbott has received reports of discoloured beads with light brown appearance in the product (should be white). probability of occurence is 1 in 1.4 million beads.
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.
Extra notes in the data
Reason
Pressure variations generated under different circumstances (e.G. heated air flows).
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.
Extra notes in the data
Reason
Components used in the production of trudell's nebulizer kits have been identified as recalled product manufactured by unomedical inc. the issue with the recalled oxygen masks is that there could be a sticky substance on the inside and/or outside of the mask that may manifest itself in approximately 6 to 8 months after manufacture of the product. the sticky masks could result in inconvenience and in some cases there is a remote possibility of potential harm to the patient.