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 labels on both corners of the outer box are incorrect. the product label on the center of the box and all labels on the individual devices within the box are correct. specifically the corner labels on the outside of the box state serrated jumbo. the product label on the center of the box and all labels on the individual devices within the box state serrated large.
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 software anomaly that could result in incorrect sample ids printed on the runtime panel report.
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
Reports from physicians and/or patients with difficulty inflating ams 700 with ms pump cylinders. this occurred either during srugical implantation or post-operatively.
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 elecsys anti-tpo assay has been found to show a potential elevated recovery for the patient sample and control material.
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
Anesthesia machines could be attracted to mr units creating potential for user or patient 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
Potassium electrodes may not meet its six month performance life and/or show higher than expected results during calibration period.
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 maintenance release 2(mr2) implements several fixes that are related to iec compliance and corrects several other problems.
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 manufacturer's internal quality testing confirmed on 9 may 2011 indicated there may be a performance issue which may result in fam labeled products failing to amplify. the result of this failure to amplify is that mutant alleles are not called resulting in potential false negatives. during investigation of the performance issue it was determined that this product had not been licensed for use 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
The product did not have a health canada-issued device licence as per section 26 of the medical device regulations as a result the recall was issued.
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
Siemens healthcare diagnostics has confirmed a high rate of dilution check relative bias failures of greater than 2% when using v-lyte dilution check solution lots kc6d01 kc6f01 or kc6j01. newer lots of dilution check starting with kc7a01 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
Le resultat d'une recherche de parasites peut se transferer sur une requete de microbiologie au niveau de la culture. c'est-a-dire que si un utilisateur selectionne un resultat de culture pour une requete de parasitologie dans l'onglet "identification" et qu'il clique ensuite dans le champ "no. de requete" de l'onglet de base de l'ecran principal du module de microbiologie puis qu'il entre un numero de requete de microbiologie (ou scanne une etiquette de requete a l'aide d'un lecteur code-barres) le resultat de la requete de parasitologie present a l'ecran se retrouve dans la requete de microbiologie appelee a l'ecran. le resultat de la requete de microbiologie est remplace par un resultat de parasitologie.
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 defect was discovered in isite pacs that may cause patient image orientation markers to be incorrectly labelled on multi-planar reformation images.
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
Steris corporation has learned that a limited quantity of hydraulic column cylinders installed into certain 5085 and 5085srt surgical tables were assembled by the supplier with incorrect snap rings and an anomaly in the tilt cylinder. these conditions may affect the flow of hydraulic oil through the tilt cylinder and have the potential to affect the user's ability to move the table top out of the full right tilt position.
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
Purpose of this recall is to inform about changes to the adverse event labeling for medtronic spinal cord stimulation therapy. the issue is the potential for patients to experience spinal cord compression weeks to years after implant of spinal cord stimulation (scs) lead. spinal cord compression can lead to neurological deficit due to the formation of reactive fibrous tissue sometimes with an inflammatory component. the time to onset for spinal cord compression ranges from weeks to over 17 years and may progress after lead removal.
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
Defective ac power cords. reports received of sparkling charring and fires on the plug of the power cord.
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 main screen for details - main update for cathcor lx desktop.
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 cd2 assay value assigned for the affected kits is incorrect and may cause a delay in the ability to report cd2 values if the control values are out of the assigned range.