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.
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Reason
Manufacturer has received 12 complaints indicating local speed control control for the pumps has not functioned properly resulting in pump adjustment not occurring.
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.
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Reason
The label for colorwright phosphate buffer solutions distributed in canada lacks the manufacturer's name and address as required in canadian medical devices regulations (sor/98-282) subsection: labelling requirements 21 (1).
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.
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Reason
Siemens has confirmed that version (v1.0) of the data management software (dms) cd was packaged with some xprecia stride coagulation analyzers. the version of the dms cd should have been v1.1 as this will match the version of firmware pre-loaded on the analyzer. these two versions must match in order to provide full functionality to the analyzer.
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.
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Reason
Product package seal may be defective thereby compromising sterility.
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.
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Reason
Firm has confirmed a positive bias on the patient samples on the vitros anemia controls.
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
Ortho clinical diagnostics (ocd) has received several complaints regarding quality control fluid results that are below the measuring (reportable or dynamic) range for generation (gen) 72 of vitros chemistry products nbil dt slides when calibrated with vitros chemistry products dt calibrator kit lots 37 and 38.
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 product deficiency was identified due to a shift up in patient results when using architect ca 19-9xr assay lot numbers 08851m500 08853m500 and 10040m500. these lots are demonstrating a shift up in patient results. abbott controls however do not detect the upward shift and will test within range. all other in-date reagent lots are not affected by the shift. the impacted lots all share the same conjugate component.
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
Internal testing indicates a low recovery of the platelet parameter. affecting platelet calibration.
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
Boston scientific is initiating a product advisory for a subset of imagert ii angiographic catheters. following a field report boston scientific has determined that some units within a single lot were missing the bottom pouch seal. this was caused by an alternate label reprint process which resulted in the units missing a step in the packaging process. although boston scientific has confirmed that only one batch was missing a bottom seal as a precautionary measure we are notifying all customers of this issuethat received batches processed through this alternate label reprint 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.
Extra notes in the data
Reason
May fail to conform to a claim made by the manufacturer or importer relating to its performance and may be hazardous to health: the silicone column of the septum of the bd q-syte luer access split septum device is torn resulting in leakage of blood or infusate from the side holes or the remote potential for air bubbles to enter into the bloodstream if a negative pressure/vacuum situation is created. date the event was first identified: december 24 2014. description of how the event was identified: an increase in the number of complaints for this product was identified internally. note that there have been no complaints for air in the line related to the use of the device with a peripheral iv or a cvc line. there have also been no complaints for this product from canadian customers.
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
Philips has discovered through customer feedback and internal testing the following issues: 1. a failure with the image disk may cause the entire image processing chain to be blocked due to a sw design error. this causes image data to be lost and eventually loss of live imaging functionality. 2. a filament error that may occur during the execution of an xperct. when the filament error occurs the run is aborted. after abort new x-ray runs can be started immediately without system restart.
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.
Extra notes in the data
Reason
Sterile packaging integrity/sterility assurance. a failure in the sterile peel pouch has been discovered during a quality control inspection. this failure may result in a small tear in the pouch of the device leading to a potential compromise of the sterile barrier. a leak in the sterile barrier may allow contamination of the device increasing the risk of infection. after the failure was identified a comprehensive investigation has shown an occurrence rate of less than 0.01% for the affected 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.
Extra notes in the data
Reason
There have been reports of a burning smell/smoke coming out from the upper ventilation grids of the artis dialysis machine. the events have been associated with a limited number of power supply units manufactured with a specific batch of capacitor. the technical analysis identified that the issue was caused by a defective capacitor inside the power supply unit which has the potential to melt after approximatively 4 years of 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.
Extra notes in the data
Reason
A dealer called to report that a rollator returned by a customer had a faulty brake that would not lock - it was "jammed". they could not determine the cause of the problem and asked us to inspect.
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
Cardinal health has been informed by beaver visitec of a field safety notice for the beaver xstar safety knives (contained in the cardinal health kits). the knives feature an integrated retractable safety shield to minimize the risk of accidental surgical blade injuries during handling. beaver visitec has received 20 complaints in which the protective shield was retracted thereby exposing the blade. the knives are provided in a tyvek covered tray and customers are advised prior to opening the tyvek tray to visually confirm that the plastic shield is not retracted. if the shield is in the retracted position the knife remains fully functional for its intended 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.
Extra notes in the data
Reason
During review of previous records vs current criteria positive microbiological culture results were identified.
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
Measurement errors could occur when using stenosis anaylsis software. if innova sense patient contouring is activated on smart handle or smart box the capacitive sensors may not detect small objects.
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 primary labels of the affected vials of m3639 were mislabeled with an incorrect concentration of 180 mg/l which is ten times higher than the correct concentration of 18 mg/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.
Extra notes in the data
Reason
It was reported that a vaginal cylinder (ppsu) contained some debris left over from the manufacturing process on the inside of the cylinder. problem was reported during qc check. no patient was involved.
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 situation was reported to roche regarding folate iii reagent kit lot 189895-01 that was released from the production line and did not contain the reagent nor the pretreatment. the frequency of occurence is considered to be very lot (less than 0.1%).
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 issued a communication to all customers with information on recommended blood tubing sets to be used with baxter instruments and positioning of these blood tubing sets.
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 purpose of the recall is to replace data transmission cable (usb-cable) connecting the innocor device with an external computer. the replacement usb cable will provide galvanic isolation of the innocor from the external computer via opto-couplers as opposed to the grounding protection currently in 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.
Extra notes in the data
Reason
Cell-dyn 3700 customers had reported occurrences of visible fire and smoke from the analyzer. in addition all cell-dyn 3200 customer reported smoke from the analyzer. returned power supply units were analyzed and were identified to contain the incorrect fuse for the electrical configuration at the customer site. an additional corrective action is being taken for the cell-dyn 1700 instruments.
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.