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 quality control found that the matrx plus may incorrectly position the mandible during a test up to 2mm. the device's functional check may also allow the device to be used with a positional inaccuracy of up to 0.5mm.
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.
Notas adicionales en la data
Causa
New metal cannula assemblies are scheduled for launch in june 2009. these new metal cannula may have a tolerance stack up issue with selected lots of these scissors.
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
Radiation therapy treatment plans with 2 separate targets for a patient were created with a non-brainlab treatment planning system. these targets were imported into the brainlab exactrac 5.5 system used for the positioning of the patient at the linear accelerator.
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
Incorrect expiration date on lot of stem-trol control cells printed as 01 nov 2006 should read 11 jan 2006.
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
Bard is informing customers of a label change to a component in the listed bard access systems (bas) trays and/or kits. the component skin prep pad (part number p-1010) manufactured by aplicare inc. will no longer be labeled as sterile (new non-sterile part number p-1030). over the next several months bas will deplete inventory of the sterile-labeled product and transition to the modified labeled product in its trays and/or kits. no product return is required.
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 is labeled as ai-0030-s batch 25012 but an ai-0028-s batch 248000 is inside the packaging. product is labeled as ai-0028-s batch 248000 but an ai-0030-s batch 250212 is inside the packaging. based on acumed's health hazard evaluation there is no additional risk to health tot he end user of this product. acumed received a customer complaint on 7/22/2011.
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.
Notas adicionales en la data
Causa
The instructions for use (ifu) sent with the product prior to 2004 indicates the allowed number of sterilization cycles is 100. the current version of the ifu indicates that the allowed number of sterilization is 25 and is the accurate limit for the flexible probe with a blocking washer gm11002420 usage.
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 device is now contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies as the device may become dislodged. devices to be relabelled with new contraindication.
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
Significantly decreased crp values may be obtained form samples taken from patients who have been treated with carboxypenicillins.
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 reports of disruption of mechanical ventilation disruption of n2o and disruption of anesthetic gas caused by a component in the a-ev1/a-fgc1 cpu boards.
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 potential risk has been identified where leakage may be observed on the trifurcated component at priming and during infusion. a leak in the extension set may cause a delay of infusion an under - infusion or potentially air entering the fluid path.
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
Medtronics has informed alcon that a recall is being conducted due to possible contamination with human blood caused by handling of the covidien vistectm x-ray detectable sponges during the manufacturing process and prior to final packaging and ethylene oxide sterilization. alcon used sponges from one of the affected lots to build custom paks.
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
Roche received a customer complaint regarding elevated imprecision and too high recovery of stfr control set level 1 and dup alarms during calibration with the reagent tq soluble transferrin receptor (stfr). the issue of elevated imprecision was confirmed by internal investigations on lot 606449 on cobas c 501 showed elevated imprecision of up to 8.9%. the other current reagent lots are not affected by this issue.
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 underestimation of n latex lp(a) values by 60% and an overestimation of n latex adnase b values by 80% could be observed if n latex lp(a) determined directly after homocysteine with n latex hcy.
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
On 08-dec-2015 the health canada license of the coaguchek xs lancing device has been deleted by error although the product was continued to be distributed in the coaguchek xs 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
Therapist may inadvertently change couch & machine parameters by using override/acquire actual button on 4d console which may in turn be applied to treatment plan. if not observed mistreatment may occur.
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 potential gradient amplifier issue when using the opart mri system equipped with the opart integrated electronics cabinet excluding opart ultra 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
The use of positions 9 and 10 of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe. damage to the prep probe will render the instrument inoperative with the potential to delay reporting of 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
There is a possibility to obtain falsely elevated anti-tg results caused by the interaction with high thyroglobulin (tg) concentration (>2000ng/ml) present in patient sample.
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
Pinning of the anterior holes potentially causes interference when punching.
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 the aquilion system the following software issues have been noted (1)the confirmation may not be displayed properly during scanoscopy (2)if the pgp hard split option is used and the scano skip button is pressed the second scanoscopy may not be completed (3)the use of pgp hard split may result in an error in image display processing (4)if more than 10 characters is entered in the image comment the system software will terminate abnormally. (5) under certain circumstances if the helical skip button is clicked during one of the scanning the next helical scan may stop before it is 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.
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 incorrect positioning of the wire harness can allow wire(s) to be pulled from thier intended position and become "caught" under the motor mounting bracket located under the powerchair.
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
Mechanical impacts to the tube may cause the power unit to reset and cause the system to go into bypass mode. this update (installation of safety circuit) will reduce the frequency of resets.