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
Large holes were detected in the thermoformed tray of certain sterile packaged units meaning the sterile integrity cannot be guaranteed.
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 os-a-642100 can develop fatigue cracks in normal use over extended period of time and ultimately separate completely. since there is hardly any visible or audible sign indicating potential breakage they strongly recommend retrieval from the field.
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
Potential reporting error with the clinitek novus analyzer when using the novus pro 12 urinalysis cassette. when albumin creatine or protein displays an"err" message when clinitek novus pro12 urinalysis cassette is used the clinitek novus analyzer may still report p:c or a:c ratio value.
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
Ocd determined that extension springs on some vitros systems may be out of the manufacturing specifications. extension springs are part of the slide alignment guide assembly. during an internal evaluation in our manufacturing facility it was discovered that an extension spring had insufficient force. if the extension spring does not provide sufficient force microslides may not be properly positioned within the microslide incubator which has the potential to cause imprecise results. extension springs are just one component in the slide alignment assembly. our evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely. to date ocd has not received any customer complaints 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.
Extra notes in the data
Reason
Unit updates. this correction is a performance issue not related to patient or operator safety. the deadline to complete this modification is april 17 2003.
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 client reported that some reports were not being published. omnitech found out on march 17th that the publishing of certain reports was not performed due to a stored procedure that failed between february 28th to march 17th 2017.
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
This is a followup to the recall of april 2004 regarding an anomaly that may occur when changing the name of a medication baxter is now providing a cd with a software upgrade.
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
Affected spacelabs' portable patient monitors may stop working when on ac power or shut down and do not power on again. the failure mode is caused by the capacitor identified as c329 malfunctioning and initiating a monitor shutdown.
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
Teleflex is recalling these products due to an error in labelling.
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 an internal review beckman coulter determined that the following global harmonized system hazard classification warnings and european hazard classification warnings for reagent well r1b are missing from the current access stfr instructions for use (ifu) versions.
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 third party supplier for material used to manufacture the restoration modular components has demonstrated poor process control which has raised concerns about the quality of the raw material supplied. as a precaution and due to the potential impact on the mechanical properties of the affected products stryker is recalling all products manufactured from material supplied by this supplier.
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
Product is not supporting the growth of haemophilus influenzae atcc 10211and other haemophilus species. there is the possibility of a false negative result no growth haemophilus if it were present in a clinical sample. upon investigation the ph was above specification on 2 batches that fail to support growth of h. influenzae.
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
Silicone tubing from spare kit installed during routine service may burst. replacing the silicone tubing in the z-head of autostainer link 48 (as480) instrument.
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 received reports of a variation in the red cell concentration and this was confirmed that is may cause inaccurate 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.
Extra notes in the data
Reason
Ocd has received complaints from customers reporting that caps on several reagent red blood cell product vials are too tight. in some of those complaints customers reported breaking or cracking of the glass reagent vial while attempting to unscrew the cap prior to 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
On november 28 2013 a complaint was reported to the manufacturer indicating that "when opening images for patient 'a' patient 'a' images show but the report shows for a different patient 'b'. cardiologist is looking at the wrong hemodynamic report data.
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 following issue is being addressed by ge healthcare file no. fmi 34066: the evair component manufacturer imtmedical ag is conducting a field corrective action. imtmedical has identified that potential friction of cables and tubing internal to the evair compressor may result in an inability for the compressor to output compressed air. there is a potential for temporary oversupply of oxygen to the patient as a result of this failure because the ge healthcare ventilators are designed to ventilate with 100% oxygen in the case of loss of input air supply pressure.
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
Some syringe kits may not clearly display fluidot (s) on the outside of the 115ml saline syringe barrel.