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
Two reagent lots may exhibit lower relative light units (rlus) than expected which in turn may result in controls out of range or patient results higher than expected.
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
High low mechanism wherein material used to make component to support upper deck can yield and allow upper deck to collapse to lowest position. caster brakes can be fractured if bed is moved.
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
Workaround protocol to prevent the system from incorrectly assigning results to a sample when scheduling by rack id.
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 has determined that e.Cam or symbia systems with foresight detectors performing gated or dynamic acquisitions may lose some detector time-information. this means that the framing of the image data and the calculated ejection fraction values may be lower.
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 low possibility (less than 0.05%) that the primary package blister may have a crack that can cause a loss of sterile integrity.
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
Icu medical inc. has identified a potential leak with certain monitoring kits that contain the transpac iv transducers. a small number of these devices may have the potential to leak or potentially introduce a small amounts of air into the line.
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
Observed accurate tsh results accompanied by "abnormal reaction" errors when processing flexes.
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 has identified the following four (4) issues with the products: issue 1:there is a potential for misidentification to occur when the system is configured in languages other than english or chinese. the characters #@[]`{|}~ are substituted or omitted in other languages. the issue affects the gens lh750 lh780 lh500 and dxh 800. issue 2:independent of language the dxh 800 omits the characters *?" when used as part of the selected demographics including specimen id and patient id. issue 3:in the dxh 800 space(s) used as leading character(s) in a patient or specimen id can cause random insertion of extra character(s) within that identifier. issue 4:the lh500 instrument omits the tilde character (~) from the barcode when read by the primary mode (automatic aspiration) scanner.
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 number of wireless foot control panels which is an accessory to the carl zeiss meditec opmi family of surgical microscopes have been experiencing problems with the initial connection in wireless mode.
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
Transilluminator model bf-150 has not been approved or cleared for marketing (considered an unapproved device) and therefore represents a potential health hazard.
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 has been reported that under certain circumstances when starting the system up or reconnecting the c-arm cable to the main unit the error 5000/243 "no x-ray - fd re-initializes" may occur. the error refers to a potential hardware malfunction which requires a part replacement. when this error occurs the system will become inoperable (i.E. no x-ray) until the affected part is replaced.
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 internal product review determined that there was an issue with software versions 2.60/2.4.0.0 and 2.61/2.4.1.0 for the clinitek status+ connect systems which could potentially affect patient results. in the case that an operator transmits all of the data stored in the instrument to an lis or data manager by selecting the "send all" function the software will allow the operator to perform a urinalysis strip or cassette test while data is still being transferred. in this case the instrument may be slow to respond. depending on the amount of data being transferred and the speed at which it is transferred there may be a delay in timing when the urinalysis reagents are read by the analyzer. this delay in read time may potentially affect patient 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
This recall has been initiated because these versions of (icea) allow images to be stored to the icea without pixel data. a side effect of images without pixel data is performance degradation caused by the system continuously attempting to route the images to the peer system that fail to store.
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 for drip chamber leakage or tubing disconnection from the drip chamber.
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
Stryker has become aware that there is a low likelihood of incomplete engagement of the spring arm circlip during service or replacement of the spring arm. if the spring arm circlip is not fully seated the spring arm could separate and fall along with the surgical lights monitors or navigation cameras mounted to the end of the spring arm.
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
The machine reports erroneous white blood cell counts.