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
Draeger has become aware of cases in which the fabius mri or parts of the system were attracted by the magnetic field of the mri. if the fabius mri is positioned too close to the mri the magnetic force of the mri can loosen parts of the fabius mri and cause personal 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
Compact discs received for ezmanager max diabetes management software packages were identified as being blank when used in a computer.
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
Safety alert communication issued for additional instruction in some cases not included on labeling for viaflex container with connector: do not use flexible solution container if the administration port protector is not in place prior to use. baxter requested customers to not use flexible solution containers if the administration protector is not in place. the port protector serves as a sterility barrier and if port protector missing sterility of administration port may be compromised potentially placing atients at risk of blood stream infection due to microbial contamination introduced to the fluid path. no associated deaths or serious injury related to 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
Higher than normal number of false negative tests for anti-fya. product lots involved showed reduced potency with respect to the detection of antibodies to the fya human red cell antigen. see 019978.
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 corometrics 174 series products were shipped incorrectly identifying the power cord as cf type for the fetal ecg function. although there is no iec standard requiring that fetal ecg parts be cf type a new power adaptor will solve this problem by making the product compliant to the cf type labeling on the product.
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 central lumen within the basket may not be properly positioned.
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 complaints of battery swelling over-heating and excessive discharges and have a potential to compromise the performance of the pump.
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
Inaccuracies in dwell positions within the ring can lead to unintended dose delivery if the individual applicator is not characterized by the user.
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
Beckman coulter inc. has identified four issues with the unicel dxh 800 coulter cellular analysis system: 1.Specimen tubes may fall out of a type a cassette when the analyzer inverts the cassette in the mixing station or when an operator manually inverts a cassette. 2.The dxh 800 may fail to meet the carryover specification for the wbc differential (diff) when the wbc is greater than 70 x 103 cells/ul (70 x 109 cells/l). 3.The dxh 800 may fail to meet the carryover specification for nrbc% when the wbc is greater than 50 x 103 cells/ul (50 x 109 cells/l). 4.The handheld barcode scanner does not read barcode labels using nw 7 symbology.
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 potential for the unit to tip when the articulating monitor arm is fully extended sideways from the base of the workstation.
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
Cartridge error 1.08 indicating a reference reading outside the electronic limits may result in clinically significant high readings of glucose and lactate 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
Leica biosystems recently became aware that the novocastra liquid mouse monoclonal antibody renal cell carcinoma marker lots 6036120 6032345 and 6023543 do not function as intended up to the expiry date on the product labelling and subsequently may lead to inadequate or weak tissue staining. there is a link between the age of the product and staining intensity. when used according to the instructions for use with appropriate positive controls the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. this issue is limited to this product and the lot numbers listed.
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
Potential for mis-identification of p. aeruginosa isolated from cystic fibrosis patients using manual or instrument panel reading and potential for lwered mic results when panels read with autoscan-4.
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
Spacelabs healthcare learned through internal testing that the power supply attachment screw may damage an internal component and causes the monitor to not turn on not turn off or involuntarily shut down. the screw used to attach the power supply to the monitor may come into contact with a capacitor on the internal power supply pcba causing the capacitor to crack and the monitor to fail.
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
Leaky compressor gaskets in the bvs 5000i consoles on the high side compressor. low flows were observed.
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
Wright medical technology inc has determined that affected lots indicate "ti plasma spray" on the label rather than "porous".
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.