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
Medline industries received a recall notice from medtronic concerning the covidien curity eye pad oval. medtronic has identified several lots of the eye pad oval where the sterile packaging may be compromised. the eye pad oval is a component in some medline custom or procedure packs. medline is therefore issuing a recall for the packs containing the eye pad.
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
Livanova is notifying customers that certain model 105 aspirehc and model 106 aspiresr vns therapy generators are subject to the potential for reduced battery longevity associated with the manufacturing process used to assemble the circuit board. physicians of patients with implanted devices are being notified to monitor their impacted patient(s) frequently to check battery status. only model 105 devices were imported and distributed 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
See menu 8 - field 14 as description does not fit in this space.
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
Directions for use(for these sap devices) were updated due to the increase incidents associated with cross threading over-tightening and/or damaged threads.
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
Failure to retract or park the varian mlc leaves prior to use of the demountable brainlab m3 could result in the varian mlc leaves interfering with treatment field defined by brainlab m3 without an interlock being asserted. when a demountable brainlab m3 mlc is installed on a varian accelerator the use of two a-b switches is required to deploy the desired mlc. both switches must be set to the correct position prior to use. the first a-b switch box connects the mlc workstation to either the varian mlc controller or to the brainlab m3 controller. the second a-b switch box connects the clinac console to either the varian mlc controller or the brainlab m3 controller. this connection includes the mlc interlock used to inhibit radiation from the clinac accelerator. the mlc that is not selected on this a-b switch is disconnected from the interlock circuitry.
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
Through post market surveillance flow restriction was detected from all arterial cvp and pa lines during priming and flushing. flow restriction was found inside iv trifurcated adaptor. the iv tubing lumen was blocked by the adaptor and restricted flow paths to extension tubes and pressure lines.
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 condition was identified where a small percentage of catheters may have a condition in the inflation lumen that may result in diflation difficulties.
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
Thiopental sodium may interfere with the sodium potassium and calcium readings on the gem instrument systems.
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 slots may not be large enough to slip over the stem of an e-cylinder type gaz tank in order to open and close the valve.
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
Ortho clinical diagnostics (ortho) has initiated this recall due to an inability to calibrate vitros chemistry products hba1c reagent kit generation (gen) 06 when using: vitros calibrator kit 31 lot 3155 and specific assay data diskettes ortho determined that there is an incorrect value (data/calibration mathematics) on adds (drv 5873 5874 5875 and 5876) for vitros calibrator kit 31 lot 3155 used to support vitros hba1c reagent kit gen 06. the incorrect value will prevent a successful calibration of the assay.
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 possesses non-conforming tip geometry reducing the efficiency of drilling action requiring more force and potentially heating the bone surface during operation.
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
Two occurrences of lithium-ion battery overheating have come to carestream's attention. the overheating caused the plastic battery casing of the drx detector to melt which can cause burns or other injury.
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 dental is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard instructions for use (ifus). all listed products were missing supplemental ifus. affected customers are being provided with instructions on how to obtain the supplemental ifus from the website ifu.Zimmerdental.Com or by contacting zimmer's e-labeling services section.
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
Potentially defective head drives (a plastic carry arm within the head drive is defective). if the failure mode does occur it could prevent the cpr quick release mechanism from operating properly.
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 there is potential that an electrical connection in the equipment cabinet has not been installed correctly. in potential fault scenarios (e.G. if several live wires become defective) and under certain conditions this may prevent a safety mechanism on the system side from taking effect thus compromising the electrical safety of the system. the resulting potential hazard situation has not yet occurred. the issue identified is exclusive to systems of type artis q and artis q.Zen.
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 lots of identicult albicans test kits were incorrectly shipped. shippping requirements for this product include ice packs to be added to the shipping carton. affected lot numbers were shipped incorrectly without ice packs which could potentially lead to incorrect results if the product has degraded during shipping.
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 may not be stable through expiration date on 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
Due to a manufacturing issue with ammonia ultra reagent list number 6k89-30 lot 50083y600 is being removed from use. this lot is producing results below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. quality control results are not affected.
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
Terumo cardiovascular systems (terumo cvs) received eight complaints since september 2008 of drive motor failure of the sarns centrifugal system of the terumo advanced perfusion system 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.
Notas adicionales en la data
Causa
Trinity biotech initiates a corrective field action for trinical reference plasma product code t5102 (lots r332037 r332037r and s287001). the protein c chromogenic value is misassigned in the these lots and can result in an erroneous protein c chromogenic activity result.
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
Nacetylcysteine present in the blood of patients treated for paracetamol overdose can interfere with the trinder action that uses hydrogen peroxide catalytic on aminoantipyrine and phenol and can produce falsely low results with the reagents using the trinder reaction method.
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 become aware that the spo2 and non-invasive blood pressure (nibp) waveform and numeric values displayed on the device may freeze resulting in the display of measurements that are not current. although spo2 and nibp monitoring and alarms are no longer functional all other monitoring parameters are functional and visible. if this problem were to occur the device can be reset by power cycling and the reset will allow the customer to continue monitoring. however power cycling the device does not prevent the issue from recurring.
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 for these 4 lots only the open vial stability is only 5 days.