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 this product has failed tp successfully complete instrument setup. the instrument setup required an additional tube of 7 color setup beads to be 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
When operated in an "extreme position" a moderate force will cause the system to become unstable.
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
Manufacturer has received notifications of free-flow situations and investigation identified a missing platen assembly from a cassette on one set and this wil prevent the pump from occluding the tubing.
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
Baxter is issuing a product recall for all unexpired lots of 50mm 0.2 micron filter attachment product code 35 (order code h93835) due to the potential for the filter membrane layer to be missing and for particulate matter to be present in the fluid path. the affected lots were distributed between november 19 2013 and june 17 2016.
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 labelling recall related to the surgical technique guide "plate insertion instruments. for minimally invasive plate ostemynthesis (mipo)." this action has been initiated as a result of review for the previous recall of the soft tissue retractor small extendible (325.010) due to locking nut (clamping sleeve) malfunction. the revised surgical technique guides contains a precaution on page 3 stating "do not overtighten the clamping sleeve as this could lead to breakage". this labelling recall requires that customers review the new technique guides provided in this mailing and replace previous revisions with the revised copies.
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
Complaints of increased wbc background counts and/or increased fp? flagging on patient 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.
Notas adicionales en la data
Causa
Cardinal health has recently been informed by conmed corporation that they have initiated a recall of various core? suction irrigation handpieces which are found in presource kits. this action has been initiated due to identification of product with creases in the packaging seal which sometimes result in an open channel.
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 has identified a subset of various sterile-packaged femoral heads that were manufactured prior to mid-2012 and packaged in a specific configuration that failed a packaging test due to potential compromise of the inner sterile tray. this packaging configuration consists of a double sterile barrier. there are no known incidents where the outer tray was compromised - therefore the device remains sterile when delivered during surgery.
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 combined use of the synergy flex-m/shoulder coil 1.5t with other coils increases the chance of rf interaction and heating up of the coil. this may result in possible burns of the patient. this applies to all intera 1.5t and gyroscan intera acs 1.5t mr systems with a synergy flex m/shoulder coil 1.5t initially delivered as release 5.1.7 6 7 8 9 or 10.
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 bags labelled adhesive actually contain optibond fl primer.
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
Ocd has revised the storage instructions for vitros immunodiagnostic products ckmb calibrators. internal testing demonstrated that opened reconstituted vitros ckmb calibrators stored at -20 c generated invalid calibrations that were detected by positively biased quality control results. as a result you must discontinue storage of opened-reconstituted vials of vitros ckmb calibrators frozen at -20 c. refrigerated storage at 2-8 c remains acceptable. the revised ifu will be posted online shortly. in the meantime the customer communication asks that customers post this communication by each vitros system that utilized vitros ckmb calibrators or with their user documentation records.
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
Philips has discovered an issue in the m-cabinet of the digitaldiagnost. the creepage distance between the two primaray phases in the geo transformer is 4.5mm. according to iec 60601-1 (2nd edition clause 57.10) the international standard governing electrical specifications for electronic products the creepage distance for a 500v ac (as found in the m-cabinet)has to be 5.5mm.
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
This assay kit may contain an incorrect standard reagent wedge.
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
Internal investigation confirmed that c of a of biotrin controlparvovirus b19 igm is reporting an incorrect negative control range for the liaison xl application when used in combination with biotrin parvovirus b19 igm kit.
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 certain packages the seal between the white polyethylene and the clear plastic may be missing on the hand controller sheath package resulting in a potential breach of the sterility of this accessory.
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 drawing on the ifu incorrectly represents the atual filter size of the contents. where the drawing should indicate that the package contain an administration set with a 0.2 micron filter it is incorrectly illustrated as a 2.0 micron filter. the actual product in the package and the text based description on the ifu correctly conformed to the 0.2 micron filter specification for p/n 21-7339-24. it was the filter label on the drawing that was incorrect.
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
Risk of de-lamination of epoxy bond between the aluminum insert of the table spar and the carbon fibre spar itself.
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 misconfiguration of image storage within dicomstore can lead to the deletion of unarchived dicom imaging studies by mpd or cps.
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
Celsus heparin was used during the coating process manufactured from material were found to contain the contaminant over-sulfate chondroitin sulfate (oscs) mimics heparin's anticoagulant activity.
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
By the inappropriate processing of the software for the image-processing device(hdr-08a) one-shot images are saved as black images in the hard disk and they are displayed as black images on the system monitor even though these images are displayed normally on the live monitor.
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
Lot is exhibiting a drift in the background reading that may cause invalid calibrations.
Korean data is current through September 2018. All of the data comes from Korean Food & Drug Administration, 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 South Korea.