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
Chemotherapeutic concentrations of methotrexate in patient samples may carryover to subsequent samples which could result in falsely elevated folate values when performing imx folate testing.
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 exactrac vero 3.5 patient positioning system was installed by error to a canadian customer in canada despite the device upgrade not appearing on the device licence.
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
Instructions and parts to a solution to potential damage to the simview 3000 simulator arm before it travels down limit to trip the down limit switch preventing image intensifier from colliding w/ floor.
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
Del medical have determined that in rare cases a fastener within the internal counterbalance system may fail. in the event of a fastener failure the wallstand image receptor will descend to the lowest position and cannot be used for x-ray examination until repairs are completed.
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 previously discontinued health canada licensed mentor non-sterile gel breast implant sizer was incorrectly distributed to several customers in canada when the customer order was for the sterile version of the same product. the sterile version of the product is licensed with health 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
Icentral does not provide audio or visual alarms for: 1)afib vt>2 & pvc(1) when used with apexpro 2)vt>2 & pvc(1) when used with solar dash or eagle (cardiac package software 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
Device delivers the proper charge but prints the wrong number on the programmer.
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 internal complaint identified a barcode conflict between immulite/immulite 1000 follicle- stimulating hormone (fsh) lkfs reagent wedge lots 351 and 352 where both reagent wedge lots were displayed by the software as lot '01'. this could result in the incorrect reagent wedge lot being used for a kit lot if both reagent wedges were on the instrument at the same time. an internal investigation concluded that there would be no impact to patient or quality control results if reagent wedges were mis-matched. customer complaint escalations identified "adjustment overdue" or "expired" flags when immulite /immulite 1000 fsh reagent lot 351 was stored in system history and reagent lot 352 was introduced to the system. the customer (field) confirmed "adjustment overdue" or "expired" flags could not be replicated internally. note: kit lot 351 expired august 31 2014 kit lot 352 expires october 31 2014.
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 products are currently provided a label that indicates that the final torque applied to the abutment to prevent screw loosening should be 30 n-cm. to prevent abutment screw fractures the abutment torque should be reduced to 20 n-cm.
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
Stryker has received customer inquiries stating that there was no laser etchings on the exeter stem.
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
Fluoroscan mini c-arm models officemate which could experience the following failure: the flex arm connector to c-arm can break and the c-arm that is supported by the flex arm will fall down. review of the design determined that the casting wall where a threaded hole is located for a set screw is marginal and there is a possibility that should there be an impact to that area the wall could break causing >the c-arm to fall down.
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 parameters settings in the class 1 cavity comfortprep preset screen were improperly set to 0.1 watt (low power setting) durinig programming at the factory (instead of the clinical setting of 5 watts).
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
Neural signal amplifier is incorrectly labeled as a type cf applied part. the correct labels should identify them as type bf applied parts.
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
Le decompte des injections n'etait pas incremente correctement lors de l'utilisation en alternance du d-10 dual short program et du extended program sur l'analyseur d-10 hemoglobin testing 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
When using propeller t2 flair application on 3t hd systems the surface coil intensity correction image enhancement option made hippocampus brighter than images taken with the scic option off.
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 review of the medtronic internal returned goods procedures showed that there was not sufficient control to assure that returned unused devices were appropriately examined for product and/or package damage. although there have been no reports of issues related to package sterile barrier damage manufacturer has elected to issue safety notice to address this possibility.
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
Some of the vacuette quickshield with snappy safety holder have a crack at the hub which could cause the threaded neck that holds the needle to break off and expose the needle.
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 assay values on the s-cal calibration diskette do not match the values printed on the s-cal calibration assay sheets for the specified lots.
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 a negative bias for advia centaur ft4 when used with calibrator a kit lots ending in 90 on the advia centaur advia centaur xp and advia centaur xpt systems. in addition siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay. the performance of the ft4 assay when used with calibrator a kit lots ending in 90 on the advia centaur cp system is not affected. customers may continue to use calibrator a kit lots ending in 90 for the advia centaur systems ft3 t3 t4 and tup assays. internal investigations were performed using available ft4 lots. the investigation confirmed an overall negative bias when comparing calibrator a kit lots ending in 90 to previously released calibrator a kit lots ending in 89. in some instances the negative bias may cause euthyroid patient samples to result low and outside the reference interval listed in the instructions for use (ifu). quality control material and master curve material may result low and outside acceptable ranges.
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
Confirmed a negative bias for advia centaur enhanced estradiol (ee2) on the advia centaur advia centaur xp and advia centaur xpt systems when calibrating with calibrator 30 kit lots ending in 21 (c3021) as compared to calibrator 30 kit lots ending in 20 (c3020).
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 that the graft cutting block with scale had the material listed on the label as stainless steel/teflon when it is actually propylux.
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.